CN101785726A - Suction, flushing and cleansing wounds device - Google Patents
Suction, flushing and cleansing wounds device Download PDFInfo
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- CN101785726A CN101785726A CN201010119778A CN201010119778A CN101785726A CN 101785726 A CN101785726 A CN 101785726A CN 201010119778 A CN201010119778 A CN 201010119778A CN 201010119778 A CN201010119778 A CN 201010119778A CN 101785726 A CN101785726 A CN 101785726A
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- A61F13/00—Bandages or dressings; Absorbent pads
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/96—Suction control thereof
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- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract
The invention provides a kind of device of cleansing wounds, wherein carry out recirculation from the flush fluid of the bin (12) that is connected with conformal sexual trauma dressing (3) with from the wound exudate of dressing by the equipment (18) that is used to make fluid move through stream, described stream passes dressing and fluid purification mechanism (17) and turns back to dressing.Purify mechanism's (this purifications mechanism can be monophase system such as microfiltration systems, or two-phase system such as dialysis system) and remove, and make the fluid that still comprises the purification of the useful material of promotion wound healing turn back to the wound layer the deleterious material of wound healing.The invention provides the Therapeutic Method of dressing and this device of use.
Description
The application divides an application, and its female case applying date is that October 28, application number in 2003 are 200380107842.7, denomination of invention is " suction, flushing and a cleansing wounds device ".
Technical field
The present invention relates to suction, flushing and/or cleansing wounds uses device and medical wound dressing and uses this suction, flushing and/or cleansing wounds to handle the method for wound with device.
The device that the present invention is specifically related to, wound dressing and method can easily be applied to multiple wound, particularly long-term wound with cleansing wounds, is removed the deleterious material of wound healing, be retained in the useful material in some treatment aspect simultaneously, particularly useful material to wound healing.
Background technology
Before the present invention, the suction and/or the flusher that are used for this purpose are known, are used for removing the wound exudate in the trauma care process more.In the form known of this trauma care, from wound, particularly the eliminating thing that is in the wound of the state that highly oozes out is discharged into as in the collecting bag as waste liquid.
Make and remove in this way the deleterious material of wound healing.
Yet, when carrying out this treatment, for promoting the useful material of wound healing, as also left their possible best position, i.e. wound layer from somatomedin, cellular matrix component and other physiologically active component of wound exudate.
This known wound dressing and suction and/or flushing therapy system form generation under the dressing of being everlasting may cause losing the optimum performance of health autologous tissue agglutination, and postpone healing and/or cause not having the wound environment of the weak growth of new tissue of the strong three dimensional structure that is incorporated into the wound layer well and grows up to from the wound layer.This is a significant disadvantage, particularly in long-term wound.
Therefore, hope can provide a kind of therapy system, and it can be removed the deleterious material of wound healing from the wound exudate, keeps simultaneously promoting the useful material of wound healing to contact with the wound layer.
Dialysis is extracorporeal treatment body fluid such as blood with from wherein removing the known method to the deleterious material of whole body.The main purpose of dialysis is to remove this material by contacting with dialysate, also keeps as blood, cell and proteinic material simultaneously.Other material that may have additional active treatment effect might be by losing from system the permeable dialyser of this material.Thereby this material of surplus is depleted with regard to possibility in instrument for circulation of body fluid.
Be desirable to provide a kind of therapy system, it can be removed the deleterious material of wound healing from the wound exudate, and do not dilute basically contact with the wound layer to promoting the useful material of wound healing, described therapy system can provide this material continuously simultaneously and make it be recycled to Chuang Dar Industrial Co., Ltd hinders.
Because the fluid of handling turns back in the body, still be a kind of whole body therapeutic so be used to handle the dialysis of body fluid.
This with the fluid that wherein will handle external be recycled to as the topical therapeutic of wound different.
Most of dialysis also need a large amount of body fluid such as blood, and relevant equipment inconvenience is moved.
Even highly oozing out under the state, system compares with body interior, and long-term wound produces few relatively pending fluid, and the useful material aspect some treatment that need keep in wound and/or wound environment is also less relatively.
Summary of the invention
An object of the present invention is
A) avoid known suction and/or the flushing therapy system above-mentioned shortcoming at least some shortcomings and
B) provide and to remove the deleterious material of wound healing from the wound exudate, keep the therapy system that contacts with the wound layer simultaneously the useful material of promotion wound healing.
Another object of the present invention is
A) avoid in the above-mentioned shortcoming of known dialysis system at least some shortcomings and
B) provide and can remove the deleterious material of wound healing from the wound exudate, keep simultaneously contact with the wound layer to the useful material therapy system of promotion wound healing,
C) do not influence to general health.
Another purpose of the present invention is
A) avoid in the above-mentioned shortcoming of known dialysis system at least some shortcomings and
B) provide and can remove the deleterious material of wound healing from the wound exudate, keep simultaneously contact with the wound layer to the useful material therapy system of promotion wound healing,
C) portable.
The circulation that the vascularity that reaches the wound surrounding tissue under the wound is reached in described tissue often suffers damage.Another object of the present invention provides a kind of therapy system, its reservation and the following material of therapeutic activity amount is provided, and this material is useful to changing this detrimental effect, removes harmful substance simultaneously, thereby promotes wound healing.
Therefore, a first aspect of the present invention provides suction, flushing and/or cleansing wounds device, it is characterized in that this device comprises:
A) fluid flowing path, it comprises
I) conformability (conformable) wound dressing, it has
Can on wound, form fluid-tight relatively sealing or sealing backing layer and
At least one is used for the inlet tube that is connected with fluid supply line, its pass in the face of the face of wound and/or in the face of under the face of wound and
At least one is used for the outlet that is connected with fluid discharge pipe, and it passes in the face of the face of wound and/or in the face of under the face of wound,
Should or each inlet tube and should or each outlet pass in the face of the face of wound and/or in the face of the point under the face of wound, described face in the face of wound forms fluid-tight relatively sealing or sealing on wound,
The inlet tube that at least one is connected with fluid circulation tubes and
The outlet that at least one is connected with fluid discharge pipe; And
Ii) fluid purification mechanism, it has at least one inlet that is connected with fluid discharge pipe and at least one outlet that is connected with fluid circulation tubes;
B) fluid reservoir that is connected with overall flow paths by second fluid supply line (optionally or as required by means of in supply and the mobile shifter between circulating);
C) be used to make fluid to move through wound dressing and fluid purification mechanism and the equipment by fluid supply line optionally or as required; With
D) optionally be used to the to release mechanism of (bleeding) stream,
Make fluid be supplied the filling stream from fluid reservoir, and cycle through stream by equipment via fluid supply line (optionally or as required by means of mobile shifter).
Mobile shifter between supply and circulation can take to make wound to realize the form of following state simultaneously:
A) communicate with fluid reservoir, still
B) the fluid recirculation pipe close and
C) vice versa.
Therefore, if have only an inlet tube pass wound dressing in the face of the face of wound and/or in the face of under the face of wound, then by fluid supply line fluid reservoir is connected with stream by means of the mobile shifter that fluid is entered in fluid circulation tubes or the fluid discharge pipe.
In this case, the mobile shifter between supply and circulation can be actuator, as three-way valve.It is connected with fluid supply line two parts with fluid circulation tubes or fluid discharge pipe successively, thereby realizes the required mobile conversion between supply and circulation.
If two or more inlet tubes are arranged, it can be connected with fluid supply line or fluid circulation tubes respectively, and fluid supply line or fluid circulation tubes have first actuator and second actuator such as valve or other respectively and allow fluid to enter control appliance in the wound.
Close the required mobile conversion between supply and circulation of second actuator realization simultaneously by opening first actuator respectively, vice versa.
The mechanism that is used for the bleed off stream can be positioned at any suitable parts of the device that contacts with flushing liquor and/or wound exudate, but is usually located in discharge pipe and/or the circulation pipe.Yet, make it in the downstream of bin and fluid supply line and away from bin and fluid supply line as far as possible, make it can be used for from fluid reservoir via fluid supply line perfusion (prime) overall flow paths.
Rotation regulator such as valve or other control appliance such as three-way valve, conversion between bleed off and circulation is used for from device bleed off fluid to as waste liquid bin such as collecting bag.
Perhaps, may not need supply with and circulation between mobile conversion, but need the bleed off and/or the circulation of coexistence.
The latter's situation may take place when the amount of flushing liquor and/or wound exudate in the circulation increases owing to the following material of lasting adding
A) wound exudate, and/or
B) pass the fluid of the differential permeability integral body (integer) system for example such as the dialysis unit from cleanout fluid.
Can be provided for the mechanism of bleed off discharge pipe and/or circulation pipe then, it can be actuator, and as simple valve or other control appliance, permission or prevention flushing liquor and/or exudate pass the path of the bleed off pipeline that is come out by peripheral passage branch.
Fluid purification mechanism can be " monophase system " as required.
This wherein, provides for oneself at this and to remove the deleterious material of wound healing in system and make the bodies for purifying fluids that still comprises promoting the material that wound healing is useful turn back to the wound layer via circulation pipe by providing system for oneself from the circulation of fluid of wound and fluid reservoir.This system is described in further detail hereinafter in conjunction with fluid purification mechanism.
Perhaps, if suitable, can provide the form of binary system, as dialysis unit or two phase liquid extraction unit.
This wherein, pass the system that wherein fluid circulation mediate contact or (under less situation directly) contact second fluid (dialysate) phase from the circulation of fluid of wound and fluid reservoir, described more often than not second fluid (dialysate) is liquid mutually, removes the deleterious material of wound healing in this system and makes the fluid that still comprises the purification that promotes the material that wound healing is useful turn back to the wound layer via circulation pipe.This system is described in further detail hereinafter in conjunction with fluid purification mechanism.
Usually, in use, the mobile shifter between supply and circulation pipe is set at and allows fluid to enter the wound from fluid reservoir, makes wound fluid recirculation duct occlusion.
Then, open any mechanism that is used for bleed off discharge pipe and/or circulation pipe, and start equipment and the fluid purification mechanism that makes fluid move through wound.
Device capacity of stream and flushing liquor and/or from the flow major decision of the wound exudate of wound whether be fit to operational outfit with device for casting in the whole length of device stream, promptly, replace the fluid deposit (often being air) of any existence and operation from the fluid peripheral passage how long.Usually, more much more than the wound exudate in the circulation from the flushing liquor of fluid reservoir, the equipment that therefore makes fluid move through wound is fit to this purpose.
Can operational outfit device for casting in the whole length of installing stream.
Then, close the mechanism that is used for bleed off discharge pipe and/or circulation pipe usually, and be arranged on supply with and circulation pipe between mobile shifter wound convection cell bin cuts out, and allow fluid to enter the wound from fluid circulation tubes.
If fluid purification mechanism is binary system such as dialysis unit or biphase extraction unit, bodies for purifying fluids is set to contact with the whole apparent motion as polymeric film, sheet or thin film of differential permeability usually.Certainly, what cleanout fluid may be for static state under less situation, this step so then omitted.
Describe more specifically as following, in circulation, can increase flushing liquor and/or from the amount of the wound exudate of wound by the following material of continuous adding
A) wound exudate, and/or
B) cleanout fluid passes binary system such as the whole fluid that obtains as polymeric film, sheet or thin film of the unitary differential permeability of dialysis.
Additionally or as an alternative, wish by means of the equipment that makes fluid move through wound and fluid purification mechanism wound to be applied negative pressure, described equipment acts in the wound dressing downstream and circulation fluid in away from the fluid circulation tubes of wound dressing.
In this case, be desirable to provide wherein and can carry out bleed off and/or circulation system simultaneously, and wish to carry out necessary adjustment, to keep the required fluid balance of circulation by means of the mechanism that is used for bleed off discharge pipe and/or circulation pipe.
In circulation, flushing liquor and/or from the amount of the wound exudate of wound can owing to pass at cleanout fluid differential permeability in system for example such as the dialysis unit when whole fluid continue loss and reduce.
Additionally or as an alternative, wish by means of the equipment that is used to make fluid move through wound and fluid purification mechanism wound to be applied normal pressure, described equipment acts in the wound dressing upstream and circulation fluid in the fluid circulation tubes of wound dressing.
Can be similarly with wherein can supply simultaneously and/or the circulation form be provided at supply with and circulation between mobile shifter, and carry out necessary adjustment, with required fluid balance in keeping circulating by means of mobile shifter.
Be appreciated that when wound is applied normal pressure or negative pressure, should have the resilience of enough counter pressures, make flushing liquor that any significant compression or decompression can take place at least one hollow body in the circulation stream of wound layer.
In all embodiments of device, the illustrational in this article type of this body of the present invention (it is limited by film, sheet or thin film) and the material of being applicable to will have this function to a great extent.
Therefore, the body that is full of flushing liquor and limits by film, sheet or thin film, as inlet tube or discharge pipe and/or circulation pipe, with as the structure of bag, chamber and pouch, and as the suitable examples of material of the object of the backing layer of wound dressing be when exerting pressure by this way, to bring into play the thermoplastic of the suitably elastic recoil of this function.
Aspect this, the present invention has several advantages.
Advantage is the wound under the backing layer to be applied normal pressure might make one or more physiologically active components pour in tissue under the wound.
This may work under the therapeutic activity amount, compares when handling with fluid physiologically active component with independent, can promote bigger wound healing.
This physiologically active component that is of value to wound healing can be for example enzyme or other material in the exudate, and it can be supplied by the dialysis liquid extraction of fluid purification with dialysis mechanism.
Think and use suction of the present invention, flushing and/or cleansing wounds further potentiation of device periodically.
The circulation of wound fluid helps the bio signal molecular motion relevant with wound healing in the wound layer that helps wound healing process and/or move in the cell that molecule can not contact with it described in the wound of for example highly oozing out.
Suction, flushing and/or cleansing wounds in first aspect present invention are used in those embodiments of device especially true, inlet house steward or outlet header are wherein arranged, from these house stewards, the tubule radiation also is stretched over the wound layer and stops with opening, and these tubules are directly collected fluid to wound layer delivery of fluids with from the wound layer in the areal extent that increases.
These materials comprise nutrient substance, the oxygen of cytokine, enzyme, help wound cell proliferation and help other molecule such as the somatomedin of wound healing and help to cause other material of chemotactic beneficial effect (it can further be strengthened).
Use in all embodiments of device at suction, flushing and/or the cleansing wounds of first aspect present invention, special advantage is that wound dressing has and the conformal tendency of body part of using this wound dressing.
Wound dressing comprises the backing layer that has in the face of the face of wound, and described face in the face of wound can form fluid-tight relatively sealing or sealing on wound; With
At least one is used for the inlet tube that is connected with fluid supply line or circulation pipe, its pass in the face of the face of wound and/or in the face of under the face of wound and
At least one is used for the outlet that is connected with fluid discharge pipe, and it passes in the face of the face of wound and/or in the face of under the face of wound,
Should or each inlet tube and should or each outlet pass relative fluid-tight sealing of this formations or sealing in the face of the face of wound and/or at the point of facing under the face of wound.
Term used herein " fluid-tight relatively sealing or sealing " represents that it for saturating fluid and microorganism and allow maximum 50% atmospheric normal pressure or negative pressure thoroughly, is more typically maximum 15% atmospheric pressure and puts on wound.Term used herein " fluid " comprises gel-like substance such as dense condensed exudate, liquid Ru Shui and gas such as air, nitrogen etc.
The shape of the backing layer that uses can be any shape that is adapted at suction in the whole wound area, flushing and/or cleansing wounds.
The example of this shape comprises flat basically film, sheet or thin film, or other structure of bag, chamber, pouch or backing layer, as can being to comprise fluidic polymeric film.
Backing layer can be film, sheet or thin film, and its thickness (normally homogeneous thickness) is generally maximum 100 microns, and preferred maximum 50 microns, more preferably maximum 25 microns, minimum is 10 microns.
It is maximum cross over be of a size of maximum 500 millimeters (for example being used for big trunk wound), for maximum 100mm (for example being used for axillary fossa and inguinal wound) be used for extremity and be maximum 200 millimeters (for example being used for long-term wound) as veins leg ulcer and diabetic ulcer of foot.
Wish that dressing can be resilience distortion, because this can increase patient's comfort level, reduces the danger of wound inflammation.
The material that is used for this purpose comprises the synthesizing polymeric material that does not absorb aqueous fluid, as polyolefin such as polyethylene such as high density polyethylene (HDPE), polypropylene and with the copolymer of for example vinyl acetate and polyvinyl alcohol, and composition thereof; Polysiloxanes; Polyester is as Merlon; Polyamide is as 6-6 and 6-10 and hydrophobicity polyurethane.
They can be hydrophilic, therefore also comprise hydrophilic polyurethane.
They also comprise thermoplastic elastomer (TPE) and elastomer blend, for example copolymer such as acetic acid ethylethylene ester copolymer, this copolymer randomly or as required with the high impact polystyrene blend.
They also comprise polyurethane elastomer, particularly the polyurethane that forms by solution casting.
The preferred material that is used for wound dressing of the present invention comprises thermoplastic elastomer (TPE) and curable systems.
Backing layer can form relative fluid-tight sealing or sealing on every side with outlet on wound and/or at inlet tube.
Yet, particularly,, preferably have the material of high humidity permeability in the outside of fluid-tight relatively sealing along the periphery of wound dressing, flood to prevent the wound surrounding skin.It also has the fertile material of higher dampness permeability when contacting with liquid such as water, blood or wound exudate.This can be for example at Smith ﹠amp; The Allevyn of Nephew
TM, IV3000
TMAnd OpSite
TMThe material that uses in the dressing.
Backing layer is used to make backing layer to be attached to wound skin on every side in the face of the periphery of the face of wound can have for example adhesive film.
Can use for example contact adhesive, condition is that this binding agent enough makes wound dressing be the fluid-tight appropriate location that remains on hermetically along the periphery that the face of wound is faced in wound dressing.
As an alternative or additionally, in the time of suitably, can make and use up the conversion binding agent to guarantee preventing in the dressing in position that (light conversion binding agent is the binding agent that its viscosity reduces by photocuring to seepage.Use this binding agent can help to reduce damage when removing dressing).
Therefore, backing layer can have extension on every side, the flange of being made by transparent or semitransparent material or the antelabium (being appreciated that above-mentioned material also belongs among the material that is applicable to this purpose) at the nearest face of backing layer.
It has light conversion binder film in position goes up to guarantee dressing, prevents seepage on its nearest face, and have the opaque material layer on its face far away.
When removing dressing, do not cause excessive damage in order to remove dressing, before flange or antelabium are applied the radiation of suitable wavelength, remove the opaque material layer on the face far away of flange that extends around the contiguous wound or antelabium.
If in the fluid-tight relatively sealing outside, have that to make its periphery that is attached to the wound dressing of the adhesive film on the skin around the wound be to have the material of high humidity permeability or be fertile material, so, if adhesive film is successive, it also should be high humidity permeability or convertible dampness permeability, as is used for Smith ﹠amp; The Allevyn of Nephew
TM, IV3000
TMAnd OpSite
TMBinding agent in the dressing.
Make wound dressing be fluid-tight when remaining on the appropriate location hermetically along wound dressing in the face of the periphery of the face of wound when applying vacuum, wound dressing can have siloxanes flange or antelabium, with the dressing around the sealing wound.It has removed the needs to binding agent from, also can not damage patient's skin.
Inner and flow to and the flushing liquor by dressing and/or wound are oozed out logistics and be in any significant normal pressure following time when dressing, the normal pressure tendency acts on peripheral point to rise and skin around wound is removed dressing.
Therefore in this usage of device, must be in the mechanism that is provided for forming and keeps the normal pressure on this sealing or sealing, this wound of antagonism on the wound, so that play a role in peripheral point for this purpose.
The example of this mechanism comprises above-mentioned light conversion binding agent, to guarantee that dressing is in the appropriate location and prevents seepage.
Because the viscosity of light conversion binding agent is reduced by photocuring, therefore reduced the damage when removing dressing, as mentioned above, thereby on flange for example, can use the film of the stronger binding agent of aggressivity.
For being that the example of the suitable fluid adhesive that uses in the permissible more extreme condition comprises the binding agent of being made up of tissue adhesives such as cyanoacrylates basically to the damage of patient skin therein, its be applied to the wound edge around and/or the nearest face of the backing layer of wound dressing, for example on flange or the antelabium.
The suitable example of other of this mechanism comprises viscosity (as contact adhesive) and non-sticky, elasticity and stiff band, bar, circle, fillet, knot, binder such as compression bandage, sheet, cover, sleeve, chuck, sheath, parcel, socks and pipe such as elastic long tube or elastic run-down stockings, when in this way treating, it is press fitted on the limb trauma, is used to apply suitable pressure; With expandable big envelope, sleeve, chuck, trousers, sheath, parcel, socks and pipe, when in this way treating, it is press fitted on the limb trauma, be used to apply suitable pressure.
This mechanism is arranged in the wound dressing separately, extend beyond the periphery of the backing layer of wound dressing, and depend on the circumstances bonding or be attached to skin and/or wound itself around the wound, and depend on the circumstances and apply compression (as use elastic bandage, socks) to enough making wound dressing be the fluid-tight appropriate location that remains on hermetically along the wound periphery.
This mechanism can particularly become one with backing layer with other assembly of dressing separately.
Perhaps, for example can use adhesive film with this mechanism type of permanent attachment in or removably be attached to dressing, particularly be attached to backing layer, these assemblies can be Velcro
TM, promote snap-on or twistlock each other and cooperate.
Mechanism and dressing can be the independent structure of type of permanent attachment not each other.
In the design that is more suitable for that is used for the higher normal pressure on the wound, hard flange or antelabium are along the extension on every side of the nearest face of wound dressing backing layer as defined above.
Flange or antelabium are concave surface on its nearest face, to limit the passage or the pipeline of periphery.
It has the suction outlet of passing flange or antelabium, communicating with passage or pipeline, and can be connected on the equipment that applies vacuum, carries feeding mechanism as pump or electron tubes type.
Can backing layer and flange that extends around its nearest face or antelabium be become one or the two is adhered to by for example heat-sealing.
Be fluid-tight relatively sealing of formation or sealing on wound, and prevent that flushing liquor and/or exudate from passing through in the face of the peripheral below of the face of wound from wound dressing, when operative installations, is provided with dressing on the skin around the wound.
Equipment applies vacuum to flange or antelabium inside then, thereby the peripheral point place around wound forms and keep the sealing or the sealing of the normal pressure on the antagonism wound.
For above-mentioned attachment mechanism and around the wound peripheral point place form and keep the sealing above the wound of normal pressure on the antagonism wound or negative pressure or the mechanism of sealing, the periphery of preferred wound dressing sealing is a sub-circular, and is as ellipse, particularly circular.
For forming relative fluid-tight sealing or sealing with passing at inlet tube and outlet on every side with outlet on the wound, backing layer and these other assemblies are become one in the face of the face of wound and/or at inlet tube in the face of the some place under the face of wound.
As an alternative, just promotion each other of assembly, snap-on or twistlock cooperate, or adhesion or heat-sealing.
Should or each inlet tube or outlet can be the form in hole, as funnel, hole, opening, aperture, fore shaft, seam or QI KOU, be connected with the mating end of fluid circulation tubes and/or fluid supply line respectively as female part:
(randomly or as required, by being used to form the mechanism of pipe, conduit or pipe or the mouth of pipe, hole, opening, aperture, fore shaft, seam or QI KOU, as projecting member be connected with the mating end of fluid circulation tubes and/or fluid supply line respectively (randomly or as required, by supply with and circulation between mobile shifter) or
Fluid discharge pipe.
In the situation that assembly becomes one, they make (being appreciated that above-mentioned material is also included within the material that is suitable for) by same material usually.
Perhaps, be that they can be identical materials or different materials in the situation of promotion, snap-on or twistlock cooperation at them.In two kinds of situations, above-mentioned material is included in the material that is applicable to all component.
Should or each pipe pass backing layer usually rather than below backing layer.In this case, backing layer can have hard usually and/or can not the resilience bending or inflexible zone, with resist this or each pipe with should or each coupling pipe between any huge effect, or resist under pressure in any direction distortion.
Usually can make its enhancing, reinforcement or reinforcement by the lobe of distally (outside) protrusion around each the relevant pipe, conduit or the pipe that are used for to connect with the mating end of fluid circulation tubes and/or fluid supply line or fluid discharge pipe or the mouth of pipe, hole, opening, aperture, fore shaft, seam or pore from wound.
As an alternative or additionally, in appropriate circumstances, backing layer can have rigid flanges or the antelabium that extends around the nearest face of backing layer, to strengthen, to strengthen or to strengthen backing layer.
Can not comprise any integral body under the backing layer that wound dressing uses in wound.
Yet this can not provide flushing liquor is distributed in enough function surfaces so that wash the system of wound with the speed of practicality.In order to be fit to use, particularly in long-term wound dialysis, use, can advantageously provide the system that wound douche liquid wherein and/or wound exudate can distribute more equably or pass through with the path that more spirals under the dressing on the wound layer the deleterious material of wound healing with higher concentration.
Therefore, a kind of dressing of form provides " branch " shape pipe, conduit or tubule, and it stops to the radiation of wound layer and with the hole from the inlet house steward, directly circulation of fluid is sent to the wound layer by the hole.Similarly, there is wherein tubule stop and directly collect fluidic outlet header from the wound layer to the radiation of wound layer and with opening.
The pipe that radiates from inlet house steward or outlet header etc. in use can be regularly or brokenly by wound respectively, but preferably pass through wound with regular fashion.Be used for than diacope be more suitable for be designed to wherein manage etc. to the wound layer with hemispherical concentric radiation.
For more shallow wound, the example of the suitable form of this design of pipe etc. comprises that wherein pipe waits to the wound layer with the concentric radiating design of flat half elliptic.
Other example of suitable form of this design of pipe etc. comprise pipe, conduit or tubule pass the wound coverage layer at inlet tube and/or outlet backing layer in the face of the face of wound and/or stretch out from inlet tube and/or outlet in the face of the point under the face of wound those.These can have along pipe etc. and have the blind hole of perforation, hole, hole, opening, aperture, crack or seam.
Then, these pipes wait and to form respectively inlet house steward that circulation of fluid is directly sent to the wound layer effectively or directly to collect fluidic outlet header from wound.
Its hole, opening, aperture, crack or seam by the pipe on the most of wound layer under backing layer, conduit, tubule etc. carries out above-mentionedly sending or collecting.
May wish to manage, conduit or tubule be in wound and in wound dressing inside, have a good conformability the elastic elastomer structure of resilience, preferred softish structure arranged.
When treating in this way, the design of pipe, conduit, tubule etc. can be depending on the degree of depth and/or the volume of wound.
Therefore, for more shallow wound, the example of the suitable form of this design of pipe, conduit, tubule etc. comprises those forms that formed by spiral helicine one or more pipes etc. basically.
When treating in this way, for than diacope, the design that is more suitable for can be those forms of one or more pipes of comprising spirillum shape or spiral spirillum shape etc.
Be included in when using dressing the sort of of in wound circulation of fluid, perforation inlet house steward or outlet header for other suitable design of more shallow wound with blind hole.
These wherein one or both all can be this form, and another kind can be for example one or more straight type blind holes, perforation radial canal, conduit or the mouth of pipe.
What another was fit to is designed to wherein
Respectively by inlet tube, conduit or tubule and/or outlet, conduit or tubule, with circulation of fluid directly to the wound layer send or directly from wound collect fluidic inlet house steward and/or outlet header and
By with overlapped way each other the slit in the layer of type of permanent attachment form inlet house steward and/or outlet header and
By forming inlet and/or outlet, conduit or tubule (represented the exploded perspective view of this duplexer in Figure 10 a, it is nonrestrictive) in the hole in the layer of type of permanent attachment each other with overlapped way
As mentioning herein, the backing layer of use can be to be fit to therapy system of the present invention and to allow wound is applied maximum 50% atmospheric pressure, is generally any backing layer of maximum 25% atmospheric normal pressure or negative pressure.
Therefore it typically is film, sheet or the thin film of not saturating microorganism, it is flat basically, depend on any pressure reduction that is applied to it, its thickness (being generally homogeneous thickness) is similar to this film used in the conventional wound dressing or the thickness of sheet usually, be maximum 100 microns, be preferably maximum 50 microns, more preferably maximum 25 microns, minimum is 10 microns.
Backing layer can have hard usually and/or can not the resilience bending or inflexible zone, any huge effect between other assembly that does not become one mutually with opposing, and it can strengthen, strengthen or strengthen by the lobe of for example protruding.
This form of dressing can be very not conformal with the wound layer, and it can form chamber, hole or the chamber that is limited by the wound floor under backing layer and the backing layer effectively.
Wish the inside and the wound layer, especially conformal of wound dressing with the wound that is under the state that highly oozes out.Therefore, a kind of dressing form that is provided has the wound implant under backing layer.
It advantageously is to have the elastic as elastomeric structure of having of good conformability with wound shapes, and preferred softish structure.
It applies gentle pressure by himself resilience promotion against backing layer to the wound layer.
The wound implant can become one with other assembly of dressing, particularly becomes one with backing layer.
Perhaps, for example can use adhesive film or for example wound implant and described assembly be adhered to,, thereby make on the required wound fluid-tight relatively sealing or sealing can not break for example with flange that stretches out from nearest face or antelabium type of permanent attachment by heat-sealing.
In less situation, for example use that adhesive film makes the wound implant removably be attached to backing layer, or these assemblies can cooperate for promotion, snap-on or twistlock each other.
Wound implant and backing layer can be the independent structures of type of permanent attachment not each other.
The wound implant can be maybe to comprise the solid integral body that wound shapes is had good conformability, and it is elastic as elastomer structure to preferably have resilience, and preferred softish structure.
The example of the appropriate format of this wound implant foam that suitable material such as elasticity thermoplastic form of serving as reasons.The preferred material that is used for wound dressing of the present invention comprises the netted filtering polyurethane foam with aperture or micropore.
As an alternative or additionally, it can be maybe to comprise one or more conformability hollow bodies that limited by film, sheet or thin film, as bag, chamber, pouch or other structure, wherein be full of and promote hollow body and make itself and conformal fluid or the solid of wound shapes.
The thickness of film, sheet or thin film (being generally homogeneous thickness) is similar to the used film of conventional wound dressing backing layer or the thickness of sheet usually.
That is to say that thickness is maximum 100 microns, be preferably maximum 50 microns, more preferably maximum 25 microns, minimum is 10 microns, and often is to have resilience elastic as elastomeric, preferably softish.
This implant usually and other assembly of dressing become one, particularly become one, or for example use adhesive film or make its type of permanent attachment on other assembly such as flange by heat-sealing with backing layer.
The suitable fluidic example that comprises in the hollow body that is limited by film, sheet or thin film comprises gas such as air, nitrogen and the argon that is under the superatmospheric little normal pressure, is more typically air; With liquid such as water, saline.
Example also comprises gel such as silicone gel, as CaviCare
TMGel, or preferred cellulose gel, hydrophilic cross-linking cellulose gel for example is as Intrasite
TMCrosslinked material.Example also comprises aerosol foam, and wherein the gas phase of aerosol systems is for air or noble gas such as nitrogen or argon under the superatmospheric little normal pressure, is more typically air and solids such as plastics and considers to be worth doing.
Certainly, if backing layer has sufficient conformability and/or for example is the dish-shaped sheet of depression, then backing layer can be positioned at wound implant below, rather than above the wound implant.
In above-mentioned kind of design, promote wound dressing in order to make the wound implant towards the wound layer, the wound implant must adhere to or removably be attached to the skin around the wound securely.Wound implant and backing layer are not especially true in those embodiments of the independent structure of type of permanent attachment each other therein for these.
When treating in this way,, be used for this mechanism of adhering to and also can on wound, form and keep sealing or sealing in this design that is used for than diacope.
When implant on backing layer and fluid intake pipe and outlet when passing backing layer in the face of the face of wound, inlet tube and outlet can run through above the backing layer the wound implant or around the wound implant.
A kind of dressing form that provides has the wound implant below backing layer, described wound implant is or comprises by what film, sheet or thin film limited having resilience elastic as elastic hollow body, preferred softish hollow body, as has bag, chamber, pouch or other structure of hole, hole, opening, aperture, crack or seam or pipe, conduit, tubule or the mouth of pipe.Hollow body communicates with at least one inlet tube or outlet by at least one hole, hole, opening, aperture, crack or seam.
The fluid that comprises in the hollow body can be the circulation of fluid in the device then.
Then, hollow body or each hollow body form inlet house steward or outlet header effectively, this inlet house steward or outlet header is via the hole in film, sheet or the thin film, opening, aperture, crack or seam etc., or pipe, conduit or pipe etc. are directly sent circulation of fluid or directly collect fluid from wound to the wound layer respectively.
When treating in this way, the type of implant also may be to a great extent by the degree of depth of wound and/or capacity decision.
Therefore, for more shallow wound, comprise basically those that be made up of one or more conformal hollow bodies as the example of the suitable wound implant of the assembly of wound dressing, described conformal hollow body defines directly to be sent circulation of fluid or directly collect fluidic inlet house steward and/or outlet header from wound to the wound layer.
When treating in this way, be used for can be the wound implant that comprises one or more conformal hollow bodies than the more suitable wound implant of diacope, described hollow body is limited by for example polymeric film, sheet or thin film, and it is at least in part around solid integral body.This may provide convenient, the better rigidity system of handling.
Unless the wound implant below the backing layer forms effectively to have at inlet tube and outlet and passes in the face of the face of wound and/or in the face of the inlet tube of the point under the face of wound or direct-connected inlet house steward or the outlet header between the outlet, and there is the wound layer, suction and/or flushing in order to carry out the wound layer are fit to make one or more holes, passage, pipeline, path, conduit, pipe, backing layer is passed in the face of the face of wound and/or in the wound implant or the traveling around the wound implant that begin in the face of the point under the face of wound below backing layer at fluid intake pipe and outlet in tubule and/or gap etc.
In less situation, the wound implant is an open celled foam, and open celled foam has hole, passage, pipeline, path and/or the gap that can form this wound implant below backing layer.
When implant was or comprise the one or more conformal hollow body that is limited by for example polymeric film, sheet or thin film, this implant can have and allows fluid to arrive the mechanism of the wound layer below the wound dressing.
These mechanisms can be from fluid intake pipe and outlet pass backing layer in the face of the face of wound and/or begin in the face of the point under the face of wound below backing layer the wound implant or around the wound implant form of conduit, pipe, tubule or the mouth of pipe of traveling.
The suitable design of the more shallow wound that is useful on can be used under the wound implant below backing layer, described design comprise blind hole, mentioned above when using dressing the perforation inlet house steward or the outlet header of wound fluid circulating.
In a word, the design of Shi Heing comprises one of them or two house stewards
Be ring-type or annular (the rule ring is as oval or circular, or irregular ring) randomly have the blind hole of coming out from ring or annulus branch, radial pipe, conduit or the mouth of pipe of perforation, and/or
For zigzag, crooked, that curl, zigzag, snakelike or by a left side right/again by a left side, the right side (promptly as the ditch dug with a plow) pattern of embarking on journey alternately, or
By be attached to each other for duplexer the layer in seam and by layer the hole limit.
Inlet tube and/or outlet, fluid circulation tubes and fluid supply line etc. can be conventional type, as ellipse or circular cross-section type, and can suitably have uniform cylinder hole, passage, pipeline or path on its whole length.
Depend on flushing liquor and/or from the required fluid volume flow of the wound exudate of wound and in circulation required amount, the maximum in hole is crossed over size and can be suitably is used for big trunk wound and be used for limb trauma for maximum 2 millimeters for maximum 10 millimeters.
Tube wall should be suitably enough thick, to stand any normal pressure or the negative pressure of the face of being applied to it, if particularly in circulation flushing liquor and/or from the amount of the wound exudate of wound owing to continue to wherein adding the wound exudate, and/or cleanout fluid increases by the whole fluid that obtains as binary system such as the unitary polymeric film of dialysis, plate or thin film of differential permeability.Yet as following description about pump, the main purpose of this pipe is the length that fluid flushing liquid and exudate is transported to whole device stream, rather than as pressure vessel.The thickness of tube wall can suitably be at least 25 microns.
Along conduit etc. or the hole in hollow body or each hollow body or any perforation, hole, hole, opening, aperture, crack or seam can have little leap size.
They can form macroscopic view and/or microcosmic filter effectively, are used to filter the microgranule that comprises cell debris and microorganism, and allow protein and nutrient substance to pass through.
No matter implant is that solid is whole and/or one or more elastic hollow body of resilience or conformal hollow body arranged, and this have further detailed description above in about inlet tube and outlet by implant and/or at pipe, conduit or pipe etc. around the implant.
In case wound dressing in use is positioned at above the wound, suction, flushing and/or cleansing wounds should be not saturating microorganisms with the whole length of device.
Wish that wound dressing of the present invention and suction, flushing and/or cleansing wounds are inner for aseptic with device.
Fluid can be in fluid reservoir and/or wherein the remainder of fluid circulation place system comprise in the fluid purification mechanism, by ultraviolet radiation, gamma-radiation or electron beam irradiation sterilization.So sterilization reduces especially or has got rid of contacting of inner surface and fluid and any antibacterial.
The example of other method of fluid disinfection also comprises for example use:
By optionally not seeing through microorganism, crossing over the ultrafiltration that size is for example carried out for maximum 0.22 to 0.45 micron micropore; With
The fluid antiseptic is as chemical solutions, as chlohexidine and povidone iodine; Metal ion source such as silver salt such as silver nitrate; With
Hydrogen peroxide;
But the method for back relates to inner surface is contacted with antibacterial with fluid.
Fluid passes through after the sterilization in fluid reservoir, wish the inside of wound dressing, the wherein remainder of fluid circulation place system and/or wound layer even keep aseptic condition, or wish to have suppressed at least naturally occurring growth of microorganism for being in the wound layer that highly oozes out wound under the state.
Therefore, can in flushing liquor, be added in the material that this respect may be useful or in fact useful at first, and increase its amount in circulation by continuing to add as required.
This examples of substances comprises antibacterial (some of them such as above listed) and antifungal agent.
Those that are fit to are for example triclosan, iodine, metronidazole, cetab, chlorhexidine acetate, sodium undecylenate, chlohexidine and iodine.
Can add buffer agent such as potassium dihydrogen phosphate/sodium hydrogen phosphate and adjust pH, also can add Bangesic/anesthetis, as lignocaine/lignocaine hydrochlorate, xylocaine (adrenoline, lignocaine) and/or anti-inflammatory agent, to reduce wound pain or inflammation or the pain relevant with dressing.
It would also be desirable to provide a kind of system, wherein implementing fluid purification front and back, the physiologically active component of not removing the exudate that is of value to wound healing.
This can realize by the passive precipitation that for example is of value to the material that promotes wound healing such as protein such as somatomedin.
This can carry out by any point in stream, as carrying out at least one inlet tube and outlet.
The precipitation that is of value to the material that promotes wound healing can followingly be resisted:
A) in flushing liquor, add extra material at first, and increase the amount of additional material in circulation by continuing to add as required, or
B) any point or any rejection coating that uses on the whole that directly contacts with fluid in the peripheral passage is for example in the fluid purification mechanism or on any required pipe or conduit.
The example that is used for the lip-deep coating material that circulation of fluid passes through comprises
Anticoagulant such as heparin and
High surface tension material such as PTFE and polyamide,
It is useful to somatomedin, enzyme and other protein and derivant.
Suction of the present invention, flushing and/or cleansing wounds have such mechanism with device, and this mechanism allows fluid directly or indirectly to enter wound under the wound dressing with the form of the fluid supply line that is connected with fluid reservoir.
Fluid reservoir can be the type of any routine, as the pipe that can comprise flushing liquor, made by polymeric film, bag (as be generally used for the bag of blood or blood product such as blood plasma, or be used for the bag of inculcating as nutrient substance), chamber, pouch or other structure.
Fluid reservoir can be made by film, sheet or thin film, its thickness (being generally homogeneous thickness) is similar to the film used in the conventional wound dressing backing layer or the thickness of sheet usually, be maximum 100 microns, be preferably maximum 50 microns, more preferably maximum 25 microns, minimum is 10 microns, and it normally has resilience elastic as the elastic hollow body, is preferably softish hollow body.
In all embodiments of device, whole pipes and the type of fluid reservoir and the function that material depends primarily on them that suction of the present invention, flushing and/or cleansing wounds use with device.
In order to be fit to use, be specially adapted to long-term time-histories, material should be nontoxic and bio-compatible, be inert to any active component, and flushing liquor and/or wound exudate in the suitable device stream, and be fit to move to the intravital dialysate in the unitary any application of binary system dialysis of the circular flow in the device from fluid reservoir.
When operative installations, when material contacted with flushing liquor, this material should not allow the extractable of significant quantity freely to spread.
It should be sterilized by ultraviolet radiation, gamma-radiation or electron beam irradiation and/or fluid antiseptic such as chemical solutions, in case use, it should be permeate fluid not and through microorganism, and is flexible.
The suitable examples of material that is used for fluid reservoir comprises synthesizing polymeric material, as polyolefin, as polyethylene such as high density polyethylene (HDPE) and polypropylene.
The suitable material that is used for this purpose also comprises its copolymer, for example with copolymer of vinyl acetate and composition thereof.The suitable material that is used for this purpose also comprises the polrvinyl chloride of medical grade.
Although use this polymeric material, fluid reservoir has hard zone usually, resisting itself and the assembly that do not become one mutually as any huge effect between the fluid supply line of wound dressing, and it may be enhanced, strengthen or strengthen by the lobe of for example protruding.
The equipment that makes fluid move through wound and fluid purification mechanism can be any equipment that is fit to this purpose, and can work for this purpose at any suitable point.
It can apply normal pressure or negative pressure to wound, though its main purpose is to make fluid (from the flushing liquor and/or the wound exudate of fluid reservoir) move through the length overall of device stream, rather than wound is applied normal pressure or negative pressure.
If to the wound dressing upstream and in the fluid circulation tubes of wound dressing this equipment of circulation fluid administration and/or to this equipment of the fluid administration in the fluid supply line of wound dressing (randomly or as required by means of supply with and circulation between mobile shifter), this equipment applies normal pressure (that is superatmospheric pressure) to the wound layer usually.
Usually fluid purification mechanism is in the downstream of wound dressing (for this purpose, in most cases being like this), and the highest resistance is provided in stream.This especially like this, as the Ultrafiltration of being undertaken by aperture or micropore, thereby has strengthened the normal pressure that acts on wound when wherein fluid purification mechanism is monophase system.
When equipment being applied in fluid circulation tubes the circulation fluid and/or during in the wound dressing downstream and away from the fluid in the discharge pipe of wound dressing, it applies negative pressure (being pressure below atmospheric pressure or vacuum) to the wound layer usually.
In addition, fluid purification mechanism common (for this purpose, most applications is like this) is in the downstream of wound dressing and the highest resistance is provided in stream, thereby potentiation is in the negative pressure of wound.
As required, can use the pump of following type:
Reciprocating pump, for example
Round shuttle-type pump-have shuttle mechanism, the speed that is used for 2 to 50ml/ minutes moves fluid;
Membrane pump-by the pulsation moving liquid of one and two flexible membrane, check-valves is controlled the direction of fluid flow simultaneously;
Piston pump-wherein the piston pumping fluid is specially adapted to produce normal pressure and/or negative pressure by check-valves on the wound layer;
Drum pump, as: centrifugal pump
The elasticity impeller of flexible impeller pump-wherein with fluid carry-over between impeller blade and molding outer casing and make fluid skim over the shell of pump.
The laddering pump of volume-have the screw rotor and the stator of cooperation is specially adapted to viscosity higher and is filled with particulate exudate;
Rotary vane pump-by being rotatably connected in the dish propelling fluid of the band blade of driving shaft, and not pulsation when it rotates.Can restrict export and do not destroy pump.
Peripheral roller on peristaltic pump-use rotor arm acts on flexible fluid circulation tubes, forces the fluid stream in the pipe mobile with the direction of rotor.
Vacuum pump-have pressure regulator.
The type and/or the capacity of equipment depend primarily on
A) suitable or required flushing liquor and/or from the fluid volume flow of the wound exudate of wound and
B) whether be fit to or do not wish the wound layer is applied normal pressure or negative pressure and the level of this pressure that the wound layer is applied,
To obtain the optimum performance of wound healing process, also depend on such as portable, power consumption and with the factor separatory of dirt.
This equipment also can suitably be the equipment that can realize the fluid motion of pulse, successive, variable, reversible and/or automatic and/or program controlled.It is any in the pump of these types particularly.
In practice, or even from the wound of highly oozing out state, the mobile flow maximum of exudate only is 75 microlitres/cm
2/ hour (cm wherein
2Represent wound area), and fluid can be high flow (owing to having protease).The exudate level descends and the denseness change when wound healing, and for example for same wound, level drops to 12.5-25 microlitre/cm
2/ hour.
By removing wound healing is had therein as the unitary binary system of dialysis (seeing below)
In the situation of the material of evil, fluid also may lose from system by fluid purification mechanism.
This may take place by for example dialysis polymeric film, sheet or thin film, and they are except seeing through the deleterious material of wound healing, and described polymeric film, sheet or thin film can also permeate water.
Therefore fluidic balance can further reduce in the circulation, but can regulate so that this undesirable loss reduces by the mode of above-mentioned routine.
Therefore, as can be seen, comprise usually than the much more flushing liquor of wound exudate in the circulation from fluid reservoir from the circulation of fluid of wound.
Therefore, the type of equipment and/or capacity be at the fluid volume flow that depends primarily on suitable or required flushing liquor aspect this, rather than from the flow of the exudate of wound.
In practice, total flushing liquor and/or wound exudate flow are 1 to 1000 milliliter/cm
2/ 24 hours level is as 3 to 300 milliliters/cm
2/ 24 hours, taking second place was 1 to 10 milliliter/cm
2/ 24 hours, cm wherein
2Be meant wound area.
When treating in this way, the amount of flushing liquor in the circulation and/or wound exudate can change in wide scope, but be generally for example 1 to 8 liter (for example for big trunk wound), 200 to 1500ml (for example for axillary fossa with inguinal wound) and 0.3 is used for limb trauma to 300ml.
In practice, the pressure that is fit to is that maximum 25% atmospheric pressure is as maximum 10% atmospheric normal pressure or negative pressure on the wound layer, and device is operated as closed-cycle system.
The higher end points of these scopes may be more suitable for hospital application, can use the pressure and/or the vacuum of higher percentages there under specialized management safely.
Lower end points may be more suitable for domestic, or is used for field hospital, does not wherein have specialized management, can not use the pressure and/or the vacuum of higher percentages safely.
Equipment can be peristaltic pump or membrane pump, for example preferred small portable membrane pump or peristaltic pump.These are preferred pump types, particularly in order to reduce or the inner surface of blowdown pump contacts with (secular) wound exudate with movable part, and are convenient to purify.
It may suitably be the pump that wound and/or fluid purification mechanism is applied normal pressure.When impressed pressure was normal pressure, preferred pump was a peristaltic pump, as was installed in the small portable peristaltic pump of fluid purification mechanism upstream.
At pump is in the situation of peristaltic pump, and it can be for example Instech Model P720 type miniature peristaltic pump, and flow is 0.2-180ml/ hour, weight<0.5 kilogram.It can be used for domestic and field hospital.
Pump can be suitably for to apply the sort of of negative pressure to wound and/or fluid purification mechanism.
When impressed pressure was negative pressure, preferred pump was a membrane pump, for example was installed in the small portable membrane pump in dressing or fluid purification mechanism downstream.
When pump was membrane pump and preferred small portable membrane pump, one or two flexible membrane of moving liquid can be polymeric film, sheet or the thin film that for example is connected with the mechanism that produces pulse.It can provide with any form easily, particularly as piezoelectric transducer, wherein solenoid core or the ferromagnet and the core of sense of current checker, and rotational type cam and follower, or the like.
The outlet thing of dressing leads to fluid purification mechanism, is used for removing the deleterious material of wound healing from the wound exudate, and is delivered in the fluid circulation tubes again.
Suction of the present invention, flushing and/or cleansing wounds have fluid purification mechanism with device, and it can be
A) monophase system is as ultra filtration unit or chemisorbed and/or absorbing unit; Or
B) binary system is as dialysis unit or biphase extraction unit.
In the former, by providing system for oneself, in this system, remove and make the bodies for purifying fluids that still comprises promoting the material that wound healing is useful turn back to wound the deleterious material of wound healing from the circulation of fluid of wound and fluid reservoir.
Monophase system can be any in the general type.
The example of the fluid purification mechanism in this system comprises coarse filtration unit and microfiltration unit, and it suitably comprises one or more macroscopic views and/or microcosmic filter.
These are used to keep microgranule such as cell debris and microorganism, and allow protein and nutrient substance to pass through.
Perhaps, they also comprise ultra filtration unit, whole as wherein purifying for being used for to the filtering filter of the deleterious material of wound healing, for example high-throughout low protein binding polymeric film, sheet or thin film the sort of, it does not optionally see through and removes the deleterious material of wound healing, and sees through the fluid that still comprises the purification that promotes the material that wound healing is useful.
Thin film can be preferably hydrophilic polymer material, as cellulose nitrate acetate mixture, Vingon and for example hydrophilic polyurethane.
Less preferred examples of material comprises hydrophobic material, and it also comprises polyester such as Merlon, PTFE and polyamide such as 6-6 and 6-10 and hydrophobicity polyurethane, and quartz and glass fibre.
It has micropore, and the maximum of micropore is crossed over size and depended primarily on material and the permeable material thereof that selectivity is in this way removed.
The former can be removed by the micropore that for example has 20 to 700 microns maximum leap size usually, as 20 to 50 nanometers (for example removing undesirable protein), 50 to 100 nanometers, 100 to 250 nanometers, 250 to 500 and 500 to 700 nanometers.
Filter integral body can be the flat sheet or the thin film of the polymeric material that is in the forms of circling round more, as is the form of slim-lined construction, as conduit, tubule etc.
System can be the chemisorbed unit, and for example wherein layer having on their surface of granule such as zeolite or layer as functionalized polymeric can be removed site to the deleterious material of wound healing from the circulation of fluid from wound and fluid reservoir of process.
Described material can by for example chelating agen and/or ion-exchanger, degradation agent destroy or in conjunction with and remove the deleterious material of wound healing, described degradation agent can be enzyme.
This example also comprises having specificity relatively poor chemical absorbing unit and/or absorbing unit, for example wherein physical absorbent such as activated carbon or zeolite have non-specific site in its surface, and these sites can be removed the deleterious material of wound healing from the circulation of fluid from wound and fluid reservoir of process.
For the capacity of given device stream and the flow of flushing liquor, purify integral body, for example polymeric film, sheet or other chemical absorbing mechanism and/or adsorbing mechanism etc. naturally can be removed the deleterious material of wound healing with the speed of practicality.
In binary system, from the circulation of fluid of wound and fluid reservoir indirectly or (less normally direct) contact second fluid (dialysate) phase, second fluid is more typically liquid.
Therefore, in a kind of two phase liquid extraction unit of form, the second fluid phase (usually) is such liquid, its circulation of fluid directly by with surface that cleanout fluid contacts on, with circulation of fluid unmixing from dressing.The deleterious material of wound healing is moved in the dialysate, and makes the fluid that still comprises the purification that promotes the material that wound healing is useful turn back to the wound layer via circulation pipe.
The example of this fluid purification mechanism comprises that second fluid (dialysate) wherein is those of materials such as perfluorodecalin mutually.
Perhaps, in the time of suitably, can provide two kinds of fluids (circulation of fluid and dialysate) to carry out isolating form, for example polymeric film, sheet or the thin film that the intravital material of the circular flow can permeate in device or doughnut or filament by significant two-dimentional integral body.
Still like this, the deleterious material of wound healing is moved in the dialysate, and makes the fluid that still comprises the purification that promotes the material that wound healing is useful turn back to the wound layer via circulation pipe.
Provide therein in the unitary any form of binary system such as dialysis, in user mode, make dialysate move through circulation of fluid in the device usually with following current or preferred countercurrent direction.
The direction of pump such as peristaltic pump and/or two kinds of fluid flow of valve control.
Yet cleanout fluid may be static under few cases, though its system that provides may not have sufficient (power) surface so that remove the deleterious material of wound healing from the wound exudate with the speed of practicality.
With in the device, the binary system that the typical dialysate flow that is used for the dialysis mechanism of fluid purification is a general type is as being used for the used flow in dialysis unit of whole body therapeutic at suction of the present invention, flushing and/or cleansing wounds.
Integral body can be film, sheet or thin film, it typically is same-type and has same (being generally homogeneous) thickness, and is used as the dialysis unit that is used for whole body therapeutic as conventional binary system.
Film, sheet or thin film can be flat basically, and depend on any pressure reduction of crossing over it, may need other material to make it be strengthened, strengthen or strengthen in the above or wherein.
Yet this can not provide has sufficient function surface zone so that remove the deleterious material of wound healing from the wound exudate with the speed of practicality.
In order be fit to use,, may advantageously provide the system that wherein film, sheet or the thin film of polymeric material are in the forms of circling round more especially for long-term wound dialysis to the deleterious material of wound healing with higher concentration.
It can be the form of slim-lined construction, as circular cross-section, as oval or circular conduit, pipe, doughnut or filament or tubule, as having being arranged in parallel of gap betwixt.
Wound douche liquid and/or wound exudate can cycle through inside repeatedly, and cleanout fluid can enter the gap between adjacent catheter, pipe or the tubule of following current or preferred countercurrent direction, or vice versa.
Still like this, the deleterious material of wound healing is moved in the dialysate, and the fluid that still comprises the purification that promotes the material that wound healing is useful turns back to wound via circulation pipe.
In fluid purification mechanism is binary system such as the unitary form of dialysis, or during biphase extraction unit, from the circulation of fluid of wound and fluid reservoir surface by significant bidimensional integral body, for example polymeric film, sheet or thin film, it optionally sees through the deleterious material of wound healing.
Remove these by making cleanout fluid by other surface of this integral body.Integral body can be the above-mentioned film to the deleterious material of wound healing of selectively penetrating, sheet or thin film.
Above-mentioned these example comprises
Oxidant is as free radical, as Peroxides and Superoxides;
Ferrum II and ferrum III;
Related all substances in the oxidative stress of wound layer;
Protease is as the serine stretch protein enzyme, as elastoser and thrombin; The cysteine proteinase class; Matrix metalloproteinase is as Collagenase; And carboxyl (carboxylic acid) protease;
Endotoxin is as lipopolysaccharide;
From body inducement signal molecule, as the homoserine lactone derivant, as the oxoalkyl group derivant;
Angiogenesis inhibitor such as thrombostondin-1 (TSP-1), plasminogen activators inhibitor or angiostatin (plasminogen fragment)
Proinflammatory cytokine such as tumor necrosis factor (TNF α) and interleukin 1 β (IL-1 β),
With
Inflammatory material such as lipopolysaccharide and as histamine.
The suitable examples of material that is used for film, sheet or thin film (being generally the form of the conformal hollow body that is limited by film, sheet or thin film, as above-mentioned structure) comprises natural polymeric material and synthesizing polymeric material.
Thin film can be made by one or more hydrophilic polymer material, as cellulose derivative, and as regenerated cellulose, cellulose list, two or three esters, as cellulose list, two or triacetate, benzylcellulose and Hemophan, and composition thereof.
Other examples of material comprises hydrophobic material, as aromatic series polysulfones, polyether sulfone, polyether ethersulfone, polyketone, polyether-ketone and polyether-ether-ketone and sulfonated derivative thereof, and composition thereof.
Other examples of material comprises hydrophobic material, as polyester, as Merlon; With polyamide such as 6-6 and 6-10; Polyacrylate comprises as poly-(methyl methacrylate); Polyacrylonitrile and copolymer thereof are as acrylonitrile-metal sulfamate sodium copolymer; With poly-(vinylidene chloride).
The suitable material that is used for thin film of the present invention comprises TPO, as polyethylene such as high density polyethylene (HDPE), polypropylene and with the copolymer of vinyl acetate and polyvinyl alcohol, and composition thereof.
Should select the molecular cut off (MWCO) of dialyser, make it possible to optionally to pour into will from wound remove to the deleterious material of wound healing.For example, the perfusion of serine protease elastoser (molecular weight 25900 dalton) needs the daltonian thin film in MWCO>25900.The threshold value that can change MWCO is to be fit to the every kind application of molecular weight between 1 to 3000000 dalton.
Preferably, MWCO answers as close as possible this molecular weight, to get rid of bigger competitor's interference.
For example, the daltonian thin film in this MWCO>25900 do not allow any significant quantity, freely spread at the spontaneous elastoser antagonist of wound system α-1 antitrypsin (AAT) (molecular weight 54000 dalton) and to leave wound fluid and enter dialysate.To promoting the useful this inhibitor of long-term wound healing to keep contacting, and the wound layer is brought about a wholesome effect, remove simultaneously the deleterious elastoser of wound healing with the wound layer.
This application of device of the present invention can help for example long-term wound such as diabetic ulcer of foot, the particularly agglutination of decubital ulcer pressure ulcers.
As mentioned below, can use the antagonist on dialysate one side of thin film such as the chelating agen of digestive enzyme or elastoser, to promote removing these protease from the wound exudate.
Remove several differently during to the deleterious material of wound healing in hope, can advantageously provide the system of serial module structure, wherein each module is removed different materials.This makes inconsistent scavenging material to use on same fluid and/or wound exudate.
Preferred any this system is conventional programmable data system automatically, can use minimum management cleansing wounds flushing liquor and/or wound exudate.
As above detailed description, fluid passes through differential permeability integral body from cleanout fluid.
This can be binary system such as the unitary typical osmotic polymer film of dialysis, sheet or thin film.
In addition, solute or decentralized photo enter flushing liquor and/or wound exudate from dialysate by dialysis polymeric film, sheet or thin film.
This performance can be used for and will the useful material of wound healing be filled into flushing liquor and/or the exudate from dialysate.
In this more not conventional perfusion supply type, multiple material is entered exudate and/or the flushing liquor from dialysate.
These comprise
Ionic species is as bicarbonate;
Vitamin, as ascorbic acid (vitamin C) and vitamin E, and stable derivant, and composition thereof; To alleviate the oxidative stress of wound layer;
The pH buffer agent, as potassium dihydrogen phosphate/sodium hydrogen phosphate,
Bangesic/anesthetis, as lignocaine/lignocaine hydrochlorate and xylocaine (adrenoline, lignocaine) and/or antiinflammatory, with minimizing wound pain or inflammation or the pain relevant with dressing,
The nutrient substance of help wound cell proliferation such as aminoacid, sugar, low-molecular-weight are organized building block and trace element; And other cell culture material; With
Gas is as air, nitrogen, oxygen and/or nitric oxide.
For bodies for purifying fluids in device of the present invention, monophase system such as ultra filtration unit and binary system such as dialysis unit all can have as following (stable, undissolved and/or fixed) catches material, it is incorporated into undissolved and/or fixed substrate, from the flushing liquor of wound dressing and/or the wound exudate is flowed through and/or by this substrate, enter fluid circulation tubes subsequently:
Antioxidant and free radical scavenger, as hydroxytyramine hydrobromide (dopamine), ascorbic acid (vitamin C), vitamin E and glutathion and stable derivant thereof, and composition thereof; To alleviate the oxidative stress of wound layer;
Metal ion chelation agent and/or ion-exchanger are as the transition metal ions chelating agen, as ferrum III chelating agen (Fe III has participated in the oxidative stress of wound layer), as desferrioxamine (DFO), hydroxytyramine hydrobromide (dopamine);
Ferrum III Reducing agent;
Protease inhibitor is as TIMP and alpha1-antitrypsin (AAT); Serpin, (AEBSF is PefaBloc) with N α-p-toluenesulfonyl-L-lysine chloromethyl ketone (TLCK) and epsilon-amino caproyl-p-chlorobenzyl amide as 4-(2-aminoethyl)-benzene sulfonyl fluorine; Cystatin; Matrix metallo-proteinase inhibitor; And carboxyl (carboxylic acid) protease inhibitor;
By removing the material that initiation is expressed in the wound exudate the deleterious oxidoreduction sensitive gene of wound healing, may or in fact to promoting the useful sacrificial oxidation reducing substances of wound healing;
From the agent of body inducement signal molecular degradation, it can be enzyme; With
In conjunction with or destroy the anti-inflammatory substance of lipopolysaccharide, as peptidomimetics.
Can remove other physiologically active component in this way to the deleterious exudate of wound healing.
These available suitable chelating agen and/or ion-exchanger, degradation agent (it can be an enzyme) or other material are got rid of.
The functionalized substrate of following type has in its surface when the site that can remove during by them from the circulation of fluid of wound and fluid reservoir the deleterious material of wound healing:
Heterogeneous resin, for example silicon dioxide carried reagent, as
Metal scavenger,
The functionalized silica gel of 3-(Diethylenetriamine base) propyl group
2-(4-(ethylenediamine base) benzene) the functionalized silica gel of ethyl
The functionalized silica gel of 3-(sulfydryl) propyl group
The functionalized silica gel of 3-(ghiourea group) propyl group
The silica gel that the triamine tetraacetate is functionalized
Or electrophilic scavenger,
The silica gel that the 4-carboxybutyl is functionalized
The silica gel that 4-ethylo benzene sulfonic acid chloride is functionalized
The silica gel that propionyl chloride is functionalized
The functionalized silica gel of 3-(isocyano group) propyl group
The functionalized silica gel of 3-(thiocyano) propyl group
The functionalized silica gel of 3-(2-succinic anhydrides) propyl group
The functionalized silica gel of 3-(dimaleoyl imino) propyl group
Or the nucleophilic scavenger,
The silica gel that the 3-aminopropyl is functionalized
The functionalized silica gel of 3-(ethylenediamine base)
2-(4-ethylenediamine base) the functionalized silica gel of propyl group
The functionalized silica gel of 3-(Diethylenetriamine base) propyl group
The silica gel that 4-ethylo benzene sulfonamide is functionalized
2-(4-tosyl diazanyl) the functionalized silica gel of ethyl
The functionalized silica gel of 3-(sulfydryl) propyl group
The silica gel that dimethyl silane oxygen base is functionalized
Or except that alkaline agent or plumper,
The functionalized silica gel of 3-(dimethylamino) propyl group
3-(1,3,4,6,7,8-six hydrogen-2H-pyrimido [1,2-α] pyrimidine radicals) the functionalized silica gel of propyl group
3-(1-imidazoles-1-yl) the functionalized silica gel of propyl group
The functionalized silica gel of 3-(1-morpholino) propyl group
The functionalized silica gel of 3-(1-piperazinyl) propyl group
The functionalized silica gel of 3-(1-piperidino) propyl group
3-(4,4 '-trimethyl two piperidinos) the functionalized silica gel of propyl group
The functionalized silica gel of 2-(2-pyridine radicals) ethyl
The functionalized silica gel of 3-(trimethyl ammonium) propyl group
Or following reagent,
3-(1-cyclohexyl carbon imidodicarbonic diamide base) the functionalized silica gel of propyl group
The silica gel that TEMPO-is functionalized
The functionalized silica gel of 2-(diphenylphosphine) ethyl
2-(3,4-cyclohexyl glycol) the functionalized silica gel of propyl group
The functionalized silica gel of 3-(glycidoxy) propyl group
2-(3, the 4-epoxycyclohexyl) the functionalized silica gel of propyl group
The functionalized silica gel of 1-(pi-allyl) methyl
The silica gel that the 4-bromopropyl is functionalized
The silica gel that the 4-bromophenyl is functionalized
The silica gel that the 3-chloropropyl is functionalized
The silica gel that the 4-benzyl chloride is functionalized
The functionalized silica gel of 2-(methoxycarbonyl base) propyl group
3-(4-nitrobenzamide base) the functionalized silica gel of propyl group
The functionalized silica gel of 3-(urea groups) propyl group
Or above-mentioned any combination.
Use aforesaid this being incorporated into not dissolve catching on substrate and/or the immobilized substrate (stable, undissolved and/or fixed) material and be used as suitable fluid purification mechanism and be described, wherein from the flushing liquor of wound dressing and/or the wound exudate is flowed through and/or by this substrate.
Yet in appropriate circumstances, they can be used for any part that device contacts with flushing liquor and/or wound exudate in addition, but in the dressing of being everlasting, are used for removing the deleterious material of wound healing from wound.
In appropriate circumstances, fluid purification mechanism can comprise the filter of one or more macroscopic and/or microcosmic in addition.
These are used to keep microgranule, as cell debris and microorganism, allow protein and nutrient substance to pass through.
Perhaps, can using more not, the binary system of common type (referring to top) is used as fluid purification mechanism as the dialysis unit.In this type, dialysis polymeric film, sheet or thin film are not the integral body that optionally sees through the deleterious material of wound healing, described material as
Protease is as the serine stretch protein enzyme, as elastoser and thrombin; The cysteine proteinase class; Matrix metalloproteinase is as Collagenase; And carboxyl (carboxylic acid) protease;
Endotoxin is as lipopolysaccharide;
Angiogenesis inhibitor such as thrombostondin-1 (TSP-1), plasminogen activators inhibitor or angiostatin (plasminogen fragment);
Preceding inflammatory cytokines such as tumor necrosis factor (TNF α) and interleukin 1 β (IL-1 β),
Oxidant is as free radical, as Peroxides and Superoxides; With
Metal ion, as ferrum II and ferrum III, they have all participated in the oxidative stress of wound layer.
Yet it also allows wound and/or flushing liquor, can be that macromole or micromolecule but the component that helps wound healing enter and pass through.
In fluid purification mechanism, in dialysate, or preferred in one or more solid structure integral body with at least one surface that contacts with dialysate, there are one or more can remove from the wound exudate, to the material of the deleterious material of wound healing, it is
The antagonist of above-mentioned harmful substance, as enzyme or other material, as protease inhibitor, as serpin, (AEBSF is PefaBloc) with N α-tolysulfonyl-L-lysine chloromethyl ketone (TLCK) and epsilon-amino caproyl-p-chlorobenzyl amide as 4-(2-aminoethyl) benzene sulfonyl fluorine; Cystatin; Matrix metallo-proteinase inhibitor; And carboxyl (carboxylic acid) protease inhibitor;
Binding agent and/or degradation agent are as the anti-inflammatory substance of combination or destruction lipopolysaccharide, as peptidomimetics;
Antioxidant, as hydroxytyramine hydrobromide (dopamine), ascorbic acid (vitamin C), vitamin E and glutathion and stable derivant thereof, and composition thereof; To alleviate the oxidative stress of wound layer; With
Chelating agen and/or ion-exchanger are as desferrioxamine (DFO), hydroxytyramine hydrobromide (dopamine).
They also comprise peptide (comprising cytokine, as the bacterial cell factor, as alpha-amido-gamma-butyrolacton and L-homocarnosine) in addition; With
May or in fact to promoting the useful sacrificial oxidation reducing substances of wound healing, as ferrum III Reducing agent; And/or such renewable material, as the glutathion oxidation-reduction system; With
Other physiologically active component.
In the binary system dialysis unit that uses this more not common type, make multiple material enter dialysate usually from exudate.
Some (mainly being ion-type) materials can enter flushing liquor and/or wound exudate from dialysate by to dialysis polymeric film, sheet or the thin film not too strong to the selective permeation ability of the deleterious material of wound healing.
The component of wound exudate and/or flushing liquor can freely spread, and passes through back and forth.
If (preferably) do not have dialysate to be excreted to as in the collecting bag as waste liquid, then finally between dialysate and flushing liquor and/or wound exudate, set up the concentration balance of stable state, it is for " to fill " (topped up) by wound dressing.
The circulation wound fluid helps to reach quickly to promoting this balance of the material that wound healing is useful.
The circulation wound fluid also makes may useful positions, i.e. wound layer to promoting that the useful material of wound healing turns back to them.
The deleterious target substance of wound healing also by the deleterious matter selective of wound healing is seen through not too strong dialysis polymeric film, sheet or thin film, is entered dialysate from exudate.
Different with other component from wound exudate and/or flushing liquor, the deleterious target substance of wound healing is touched dialysate, or preferably contact the one or more solid structure integral body that in dialysate, have at least one surface, and remove by suitable antagonist, binding agent and/or degradation agent, chelating agen and/or ion-exchanger and reductant-oxidant etc.Still comprising some gets back in the circulation pipe the fluid of the purification of the useful material of promotion wound healing.
Different with other component from wound exudate and/or flushing liquor, above-mentioned target substance is constantly removed from dialysate, these few materials from dialysate by entering flushing liquor and/or wound exudate, it does not set up the concentration balance of stable state, even this material constantly " is filled " from wound dressing.
It is believed that the circulation wound fluid help from circulation, to remove from the wound exudate to the deleterious material of wound healing, keep simultaneously when contacting the useful material of promotion wound healing with wound.
The special advantage of this binary system form is, wherein can remove the material of the deleterious material of wound healing toxic or biological inconsistent or from the wound exudate to promote that the useful any component of wound healing is that this system does not allow the antagonist of any significant quantity freely to diffuse out and enters flushing liquor under the inert situation from dialysate for (cell).Yet these active substances can advantageously act on fluid.
Film, sheet or thin film have preferably been selected molecular cut off (MWCO) and will be chelated or the dialyser of destructive material so that can pour into.
For example, the chelating of serine protease elastoser (molecular weight 25900 dalton) needs the daltonian thin film in MWCO>25900.
Can change the MWCO threshold value to be fit to the every kind application of molecular weight between 1 to 3000000 dalton.Preferably, MWCO answers as close as possible this molecular weight, disturbs with the chelating of getting rid of bigger competition material.
Monophase system such as ultra filtration unit and binary system such as dialysis unit can be the modular forms of relatively easily dismantling from device of the present invention.System can suitably comprise one or more this modules.
A) from the flushing liquor of wound dressing and/or wound exudate and
B) still comprise fluid to the purification that promotes the material that wound healing is useful turn back to circulation pipe and
C) (provide under the situation of mechanism of binary system such as dialysis unit form) cleanout fluid to enter or leave this mechanism therein
The pipeline that passes through respectively disconnects and module is cancelled and had mechanism in module, is used for
I) disconnect to flow and
Ii) provide fluid-tight closely sealing or sealing at the pipeline of the remainder of the apparatus of the present invention that so expose and the end of fit tube,
Continue to pass through with fluid and the cleanout fluid that prevents flushing liquor and/or exudate and purification.
Suction of the present invention, flushing and/or cleansing wounds have the mechanism that is used for bleed off discharge pipe and/or circulation pipe with device, as actuator, as valve or other control appliance, are used for from wound bleed off fluid.
The equipment that use makes streaming flow move through wound and fluid purification mechanism makes flushing liquor move to wound dressing and apply required normal pressure or negative pressure on the wound layer.
If be fit to, fluidic balance is usually according to circumstances by following adjusting in the required circulation pipe
A) be used for the mechanism of bleed off discharge pipe and/or circulation pipe,
B) the mobile shifter between supply and circulation, and/or
C) make fluid flow move through the mechanism of wound layer and fluid purification mechanism.
Therefore, for example, if
A) suction, flushing and/or cleansing wounds device are monophase system, as ultra filtration unit,
B) wound be not in the state that highly oozes out and
C) be not suitable for or do not wish to make fluid to enter the wound from fluid reservoir,
Then fluidic balance does not have or has only very little variation in the circulation.
In case it has poured into normal pressure or negative pressure on the wound layer that reaches for example required, then device can be used as closed-cycle system and operates.
Supply with and circulation pipe between mobile shifter be set to close the path of wound by fluid supply line and fluid reservoir, and the mechanism that is used for bleed off discharge pipe and/or circulation pipe also is closed.
If
A) suction, flushing and/or cleansing wounds device are monophase system, as ultra filtration unit,
B) wound is in the state that highly oozes out, and/or
C) be fit to or wish that fluid enters wound from fluid reservoir,
Then fluidic balance has positive variation in the circulation.
In case poured into normal pressure or negative pressure on the wound layer that reaches for example required, then device can not be operated as closed-cycle system, and the pressure of wound layer is not increased, and this may be undesirable.
The mechanism that is used for bleed off discharge pipe and/or circulation pipe must be with open to a certain degree, to alleviate the normal pressure on the wound layer.The bleed off thing can be used as waste liquid and is excreted to as in the collecting bag.
When treating by this way, may useful positions, i.e. wound layer to promoting that the useful material of wound healing may leave them.
Yet, can regulate fluidic balance in the circulation routinely, make this unwanted minimization of loss.
The factor of fluid balance in the decision circulation is understood in the operation of above coupling apparatus in detail, and the described device that circulates in the binary system mechanism that is used for fluid purification with dialysis unit form or biphase extraction unit form carries out.It should be noted that if make whole fluid levels be increased to undesirable degree from the mobile of dialysate, then in the whole length range of device stream, set up after the stable state circulation certain a bit on, be necessary to open any bleeder valve.
Other combination, and in circulation pipe, keeping required fluid balance to pass through
A) be used for the mechanism of bleed off discharge pipe and/or circulation pipe,
B) the mobile shifter between supply and circulation, and/or
C) mechanism that fluid is moved
Necessity adjustment of carrying out it will be apparent to those skilled in the art that.
Can collect and monitor the outlet thing of the mechanism that is used for bleed off discharge pipe and/or circulation pipe, and be used to judge the situation of wound and/or its exudate.
The waste liquid bin can be the type of any routine, and as pipe, bag (as being used as the bag of ostomy bag usually), chamber, pouch or other structure of polymeric film, it can comprise the flushing liquor of having released.In all embodiments of device, the type of waste liquid bin and material depend primarily on its function.In order be fit to use, only needing material is in use can not permeate fluid, and is flexible.
The suitable examples of material that is used for fluid reservoir comprises synthesizing polymeric material, as polyolefin, as poly-(vinylidene chloride).
The suitable material that is used for this purpose also comprise polyethylene such as high density polyethylene (HDPE), polypropylene and with the copolymer of for example vinyl acetate, and composition thereof.
A kind of conformability wound dressing is provided in a second aspect of the present invention, it is characterized in that this wound dressing comprises backing layer, backing layer has the face in the face of wound that can form fluid-tight relatively sealing or sealing on wound; And have
At least one is used for the inlet tube that is connected with fluid supply line, and it passes in the face of the face of wound and/or in the face of under the face of wound; With
At least one is used for the outlet that is connected with fluid discharge pipe, and it passes in the face of the face of wound and/or in the face of under the face of wound;
Should or each inlet tube and should or each outlet by form on the wound relative fluid-tight sealing or sealing in the face of the face of wound and/or facing point under the face of wound.
Advantageously, dressing is not using in the pouch of antibacterial thoroughly.
The appropriate format of this wound dressing is as above described for example.
The objective of the invention is
A) avoid in the shortcoming of known suction and/or flushing treatment at least some shortcomings and
B) provide a kind of therapy system, described therapy system
I) can remove the deleterious material of wound healing from the wound exudate, keep simultaneously the useful material of promotion wound healing is contacted with the wound layer, and/or
Ii) make the fluid that comprises live vol enter and/or contact with the wound layer by wound to promoting the material that wound healing is useful.
Therefore, a third aspect of the present invention provides and uses suction of the present invention, flushing and/or cleansing wounds to handle wound to promote the method for wound healing with device.
Description of drawings
Below with reference to description of drawings the present invention, wherein:
Fig. 1 is suction, flushing and/or the cleansing wounds schematic representation of apparatus of first aspect present invention.
The monophase system mechanism that its fluid purification with ultra filtration unit form is used.
Fig. 2 is suction, flushing and/or the cleansing wounds schematic representation of apparatus of first aspect present invention.
The binary system mechanism that its fluid purification with dialysis unit or biphase extraction unit form is used.
Fig. 3 is to the profile of conformability wound dressing that be used to aspirate and/or wash wound of Fig. 7 for second aspect present invention.
This wherein, Fig. 3 a is the cross sectional plan view of wound dressing to Fig. 6 a, Fig. 3 b is the cross sectional side view of wound dressing to Fig. 6 b.
Fig. 8 arrives wound and collects the different views of fluidic inlet house steward and outlet header's design from wound for the delivery of fluids that is respectively applied for of the wound dressing use of second aspect present invention to Figure 10.
Figure 11 is suction, flushing and/or the cleansing wounds schematic representation of apparatus of first aspect present invention.
The monophase system mechanism that its fluid purification with ultra filtration unit form is used.
Figure 12 is suction, flushing and/or the cleansing wounds schematic representation of apparatus of first aspect present invention.
The binary system mechanism that its fluid purification with dialysis unit or biphase extraction unit form is used.
Figure 13 is to the cutaway view of conformability wound dressing that be used to aspirate and/or wash wound of Figure 26 for second aspect present invention.
Figure 27 is another suction, flushing and/or the cleansing wounds schematic representation of apparatus of first aspect present invention.
The monophase system mechanism that its fluid purification with ultra filtration unit form is used.
The specific embodiment
With reference to figure 1, suction, flushing and/or cleansing wounds comprising with device (1):
Conformability wound dressing (2), it has
Backing layer (3), its can wound (5) go up to form fluid-tight relatively sealing or sealing (4) and
One is used for the inlet tube (6) that is connected with fluid supply line (7), its (8) locate to pass backing layer in the face of the face (5) of wound and
One is used for the outlet (9) that is connected with fluid discharge pipe (10), and it locates to pass the face (5) of backing layer in the face of wound in (11),
Inlet tube and outlet be passed in form on the wound relative fluid-tight sealing or sealing in the face of the face of wound and/or in the face of point (8), (11) under the face of wound,
Inlet tube is by means of the mobile shifter between supply and circulation, here by means of three-way valve (14), be connected with fluid circulation tubes (13) with fluid reservoir (12) by fluid supply line (7), fluid circulation tubes (13) has the mechanism of this pipe of releasing, here be three-way valve (16), waste liquid is in the collecting bag (not shown) so that release
The outlet (9) that is connected with fluid discharge pipe (10), it is connected to again
Fluid purification mechanism (17) here is the form of ultra filtration unit, its by fluid circulation tubes (13) be connected with inlet tube (6) with three-way valve (14) and
Make fluid move through the equipment of wound and fluid purification mechanism (17), it here is peristaltic pump (18), as being preferably the small portable peristaltic pump, peristaltic pump uses its epitrochanterian periphery roller (not shown) to act on fluid circulation tubes (13), to apply low negative pressure on wound.
Ultra filtration unit (17) is a monophase system.Here, pass one from the circulation of fluid of wound and fluid reservoir and provide system for oneself, provide for oneself to remove in the system at this and deleterious material of wound healing made the fluid that still comprises the purification that promotes the material that wound healing is useful turn back to the wound layer via circulation pipe.
(in a variant of this device, two inlet tubes (6) are arranged, it is connected with fluid circulation tubes (13) with the fluid supply line (7) that has first valve (19) and second valve (20) respectively respectively, first valve (19) allows fluid to enter wound from fluid reservoir (12), and second valve (20) allows fluid to enter wound from circulation pipe.
Usually when operative installations, when first valve (19) when opening, second valve (20) cuts out, and vice versa.)
When operative installations (1), valve (16) is opened the collecting bag (not shown), rotates three-way valve (14) and allows fluid to arrive wound dressing from fluid reservoir by fluid supply line (7) and inlet tube (6).(in the variant with two inlet tubes (6) of this device, two inlet tubes (6) are connected with fluid circulation tubes (13) with fluid supply line (7) respectively, open the permission fluid and enter first valve (19) of wound and close second valve (20) from fluid reservoir (12), vice versa).
Start pump (18), this pump uses its epitrochanterian periphery roller (not shown) compressed fluid circulation pipe (13), and wound is applied low normal pressure.Moving this pump is poured into and excessive fluid enters the collecting bag (not shown) by means of the three-way valve of releasing (16) as waste liquid in the whole length of device stream fully up to device.
Rotate three-way valve (14) then, be transformed into circulation from supply, promptly wound convection cell bin (12) cuts out, and allows fluid to enter wound from fluid circulation tubes (13), and closes the three-way valve of releasing (16) simultaneously.
(in the variant of this device, two inlet tubes (6) are wherein arranged, they are connected with fluid circulation tubes (13) with fluid supply line (7) respectively, close first valve (19) and allow fluid to set up blood circulation from second valve (20) that circulation pipe (13) enters wound by opening.
Circulation of fluid from wound and fluid reservoir (12) is passed ultra filtration unit (17).The deleterious material of wound healing is removed, and makes the bodies for purifying fluids that still comprises promoting the material that wound healing is useful turn back to the wound layer via circulation pipe (13).
Fluidic circulation can continue to carry out as required.
By rotating three-way valve (14), the conversion between counter-rotating supply and the circulation allows fluid to arrive wound dressing from fluid reservoir by fluid supply line (7) and inlet tube (6) then.
(in the variant with two inlet tubes (6) of this device, two inlet tubes (6) are connected with fluid circulation tubes (13) with fluid supply line (7) respectively, open the permission fluid and enter first valve (19) of wound and close second valve (20) from fluid reservoir (12), vice versa).
Open bleeder valve (16) simultaneously, make fresh fluid pour in blood circulation.
Can continue process pump (18) and be poured, stop pump and fluid circulation this moment up to device.
If for example wound is in the state that highly oozes out, the fluid balance in the circulation has positive change.Be necessary to make fluid from circulation, to release, fluid released from circulation pipe (13) by opening the three-way valve of releasing (16).
With reference to figure 2, device (21) is the variant of Fig. 1 device, and it has identical and numbers identical assembly, and different is fluid purification mechanism, and this structure is the binary system form, is dialysis unit (23) here.
This wherein has a system, passes this system from the circulation of fluid of wound and fluid reservoir, contacts by carrying out selectively penetrating with second system of wherein passing scavenging solution, removes deleterious material from this system.
Therefore, dialysis unit (23) have interior polymeric thing film, sheet or thin film (24), and described polymeric film, sheet or thin film (24) optionally permeate to the deleterious material of wound healing and with dialysis unit (23) and be divided into
A) surface that polymeric film, sheet or thin film are crossed in first Room (25), cleanout fluid pass first Room and
B) second Room (26) are passed this chamber from the circulation of fluid of wound and fluid reservoir (12), and are removed harmful substance from this chamber.
Therefore dialysis unit (23) has dialysate inlet tube (28), its with lead to the dialysate supply pipe (29) of peristaltic pump (38) and be connected as preferred small portable peristaltic pump, described pump uses its epitrochanterian periphery roller (not shown) to act on dialysate supply pipe (29), makes from the cleanout fluid of dialysate bin (not shown) and supplies with the surface of passing polymeric film, sheet or thin film (28) in first Room (25) via valve (34).
Dialysis unit (23) also has dialysate delivery channel (30), its be connected via the second dialysate outlet (31) that three-way valve (36) leads to waste liquid of releasing, waste liquid is released as in the collecting bag (not shown).
The class of operation of this device is similar to the device of Fig. 1, operation except dialysis unit (23), wherein certain rinse-system has been poured and has set up fully the stable state circulation in the whole length of device stream after is a bit opened valve (34) and second bleeder valve (36).
Start pump (38), this pump uses its epitrochanterian periphery roller (not shown) compressed fluid dialysate pipe (29), and cleanout fluid is pumped into first Room and delivers to the collecting bag (not shown) as waste drains pump via bleeder valve (36) from dialysate bin (not shown).
Dialysis unit (23) is for having a kind of module (or cylindric washer) of substrate, and described substrate changes in the fluid that the color indication purified and has injurious factor, and cylindric washer exhausted, and should upgrade.
Referring to figs. 3 to Fig. 6, each dressing (41) is conformal bodily form formula, the membrane type backing layer (42) that does not see through microorganism by 25 microns uniform thickness limits, and this dressing has the face (43) in the face of wound that can form fluid-tight relatively sealing or sealing on wound.
In use, extend in the skin scope around the wound of backing layer (42) on wound.On the nearest face (43) of the backing layer on the lap (44), have adhesive film (45), make this face be attached to skin fully, wound dressing is kept in position by means of the fluid-tight sealing around the periphery of the face (43) of facing wound of wound dressing.
There is an inlet tube (46) to be used for being connected with the fluid supply line (not shown), it passes the face (43) in the face of wound and/or is facing under the face of wound, have an outlet (47) to be used for being connected with the fluid discharge pipe (not shown), it passes the face (43) in the face of wound and/or is facing under the face of wound.
With reference to figure 3a and Fig. 3 b, the dressing of a kind of form that provides has wound implant (48) below circular backing layer (42).
It comprises and is generally frustum of a cone, annular conformability hollow body, and it limits by being full of fluidic thin film (49), and above-mentioned here fluid is air or nitrogen, and this fluid impels film and wound shapes conformal.
Can use adhesive film (not shown) or heat-sealing to make implant (48) type of permanent attachment in backing layer.
Inlet tube (46) and outlet (47) are installed in the interior center of backing layer (42) on annular hollow body (48) central duct (50), and pass backing layer (42) separately, and extend through the duct (50) of annular hollow body (48) separately respectively with the form of conduit (51) and (52), below hollow body (48), extend then with the radiation of diameter rightabout.
The dressing of this form is the design that is more suitable for than diacope.
With reference to figure 4a and Fig. 4 b, be depicted as the form that is more suitable for more shallow wound.The depression disc-shaped the first film (61) that it comprises circular backing layer (42) and has hole (62), this thin film forms circular pouch (63) by the heat-sealing type of permanent attachment in backing layer (42).
Pouch (63) communicates with inlet tube (46) by hole (64), thereby forms the inlet house steward effectively, and when using dressing, this house steward directly is delivered to wound with circulation of fluid.
Ring-type second thin film (65) with opening (66) forms doughnut (67) by sealing type of permanent attachment in backing layer (42) with this layer (42).
Chamber (67) communicates with outlet (47) by aperture (68), thereby forms the outlet header effectively, and when using dressing, this house steward directly collects fluid from wound.
With reference to figure 5a and 5b, be depicted as the variant of the dressing of Fig. 4 a and 4b, be the form that is more suitable for than diacope.
It comprises circular backing layer (42) and implant (69), and implant here is that the elastic elastic foam material of resilience is arranged for the frustum of a cone solid integral body of upset, is formed by thermoplastic foam or preferred cross-linking plastic foam.
This implant can be by the adhesive film (not shown) or by sealing type of permanent attachment in backing layer (42).
The disc-shaped sheet (70) of depression is positioned at backing layer (42) and solid integral body (69) time and conformal with backing layer (42) and solid integral body (69), the disc-shaped sheet of this depression be not type of permanent attachment in the absolute construction of backing layer (42) and solid integral body (69).
Disc-shaped the first film (71) with the depression in hole (72) passes through the heat-sealing type of permanent attachment in sheet (70), forms circular pouch (73) with sheet (70).
Pouch (73) communicates with inlet tube (46) by hole (74), thereby forms the inlet house steward effectively, and when using dressing, this house steward directly is delivered to wound with circulation of fluid.
Ring-type second thin film (75) with opening (76) forms annular chamber (77) by sealing type of permanent attachment in sheet (70) with sheet (70).
Chamber (77) communicates with outlet (47) by aperture (78), thereby forms the outlet header effectively, and when using dressing, this house steward directly collects fluid from wound.
Perhaps, when in place, the form of dressing can be: wherein Ao Xian disc-shaped sheet (70) plays backing layer, and solid filler (69) places on the sheet (70) as backing layer, rather than under sheet (70).By adhesive film or adhesive tape with implant (69) rather than backing layer (42) fix in position.
With reference to figure 6a and 6b, shown in dressing be the form that is more suitable for than diacope.
It comprises circular backing layer (42) and implant (79), implant (79) is the approximate hemispherical integral body of upset, here be the elastic elastic foam material of resilience to be arranged or be full of fluidic hollow body, described fluid is a gel, it makes the shape fit of hollow body and wound, and implant (79) is by the adhesive film (not shown) or by sealing type of permanent attachment in backing layer.
Inlet tube (46) and outlet (47) are installed in the periphery of backing layer (42).
The depression disc-shaped sheet (80) place the following of backing layer (42) and implant (79) and conformal with backing layer (42) and implant (79), but the disc-shaped sheet of this depression be not type of permanent attachment in the absolute construction of backing layer (42) and implant (79).
The disc-shaped two-slices thin film (81) of depression has sealing duct (82) between its wafer assemblies, length on the outer surface (84) of the dish that is formed by thin film (81) has perforation (83), has opening (85) in its spirillum outer end, duct (82) communicates with inlet tube (46) by opening (85), thereby form the inlet house steward effectively, when using dressing, this house steward directly is delivered to wound with circulation of fluid.
Thin film (81) is between duct (82) circle and along its length also porose (86).
The dish that forms by thin film (81) inner surface (87) its penetralia point (88) by the adhesive film (not shown) or by the heat-sealing type of permanent attachment in sheet (80).This defines the sealing screw shape pipeline (89) of cooperation.
At spirillum outermost end place, pipeline (89) communicates with outlet (47) by opening (90), thereby forms the outlet header effectively, and this house steward directly collects fluid by means of hole (86) from wound.
With reference to figure 7a and 7b, provide a kind of form with dressing of circular backing layer (42).First (bigger) is inverted hemispherical thin film (92) by sealing type of permanent attachment in the center of layer (42), forms hemispherical chamber (94) with floor (42).Second (less) in the first hemispherical thin film (92) hemispherical thin film (93) with one heart forms hemispherical pouch (95) by sealing type of permanent attachment in layer (42).Pouch (95) communicates with inlet tube (46), thereby forms the inlet house steward effectively, and conduit (97) is the hemispherical radiation and is stretched over the wound layer from the inlet house steward, stops with hole (98).Conduit (97) is directly sent circulation of fluid by hole (98) to the wound layer.
Chamber (94) communicates with outlet (47), and forms the outlet header effectively thus, and tubule (99) is the hemispherical radiation and is stretched over the wound layer from the outlet header, stops with opening (100).Tubule (99) is directly collected fluid by means of opening (100) from wound.
With reference to figure 8a to 8d, a kind of dressing form is provided, first second pipe (102) of managing (101) and extending from certain point that it has square backing layer (42) and extends from certain point from inlet tube (46) from outlet (47), first pipe and second pipe extend above the wound layer, and described point is the point that inlet tube (46) and outlet (47) pass backing layer.
These conduits (101), (102) have the blind hole that has aperture (103), (104) along conduit (101), (102).These conduits (101), (102) form inlet house steward or outlet header respectively, and this house steward directly sends circulation of fluid or directly collect fluid from wound to the wound layer by means of the aperture respectively.
In Fig. 8 a and 8d, each conduit (101), (102) are spiral as a kind of design of inlet house steward and outlet header.
In Fig. 8 b, this design is the variant of the design of Fig. 8 a and 8b, and inlet house steward's (101) design is to encircle completely or ring partly, and outlet header (102) is radial conduit.
With reference to figure 8c, be depicted as another kind of suitable design, wherein enter the mouth house steward (101) and outlet header (102) with right by a left side/by right and left figure of embarking on journey alternately be ditch dug with a plow shape on the wound layer mutually side by side.
, be depicted as other and be used for suitable design than diacope to 9d with reference to figure 9a, it is identical to design shown in the 8d with Fig. 8 a.Yet, square backing layer (42) has wound implant (110) under backing layer (42), it can be by the adhesive film (not shown) or by sealing type of permanent attachment in backing layer (42), described wound implant (110) is to be inverted hemispherical solid integral body, here be that the elastic elastic foam material of resilience is arranged, form by the preferred cross-linking plastic foam of thermoplastic foam.
Be the disc-shaped sheet (111) of depression below wound implant (110), it is conformal with solid filler (110), still be not type of permanent attachment in the absolute construction of solid filler (110).Inlet tube (46) and outlet (47) pass sheet (111), extend above the wound layer.In addition, these conduits (101), (102) have the blind hole of fenestrated (103), (104) along conduit (101) and (102).
Perhaps, (shown in Fig. 5 a and 5b) when in place, can provide the dressing of following form: wherein Ao Xian disc-shaped sheet (111) plays backing layer, solid filler (110) places the top of the sheet (42) as backing layer, rather than in the below of sheet (42).By adhesive film or adhesive tape with implant (110) rather than backing layer (42) fix in position.
In 10c, being used for of wound dressing is delivered to fluid wound respectively and collects fluidic inlet house steward and outlet header by the seam and the hole of the layer of type of permanent attachment form each other with overlapped way from wound at Figure 10 a.
Therefore, in Figure 10 a, be depicted as the inlet house steward that forms by five layers of square continuous thermoplastic polymer layer and the exploded perspective view of outlet header's duplexer (120), described polymeric layer is that ground floor arrives (125) to layer 5 (121), and each layer is attached on the adjacent layer in stacked (120) mode by the adhesive film (not shown) or by heat-sealing.
Going up most (first) layer (121) (it is dressing farthest side in use) is barren square capping layer.
Next (second) layer (122), as come from shown in Figure 10 b of house steward's duplexer (120), be foursquare layer, have total pipe seam (126) of inlet by this layer.Seam (126) is used for being connected with the abutting end of fluid intake pipe (not shown), and is dispersed into four adjacent legs that are arranged in parallel, have the gap each other (128) along an edge (127) traveling of layer (122).
Next (the 3rd) layer (123) are another square layers, have inlet total pore (129) by this layer (123), make hole (129) aim at the total pipe seam of inlet (126) (shown in Figure 10 b) that passes through the second layer (122) thereby the hole is arranged as array.
Next (the 4th) layer (124), as come from shown in Figure 10 c of house steward's duplexer (120), for another square layer, have inlet total pore (130) by this layer (124), thereby being arranged as array, the hole make hole (130) aim at the hole (129) of passing through the 3rd layer (123).
Also has outlet header's seam (131) by layer (124).
Seam (131) is used for being connected with the abutting end of fluid outlet pipe (not shown) along an edge (132) traveling of layer (124), and described edge is positioned on the relative side with edges layer (122) (127) house steward's duplexer (120).
Be dispersed into the space between the hole (129) in three adjacent legs that are arranged in parallel (133) and the alignment (122) in the space between seam (131) hole (130) in layer (124).
(the 5th) layer (125) is another square layer at last, have inlet total pore (134) by layer (125), hole (134) thus being arranged as array makes hole (134) aim at the total pore of inlet (130) (aiming at the hole (129) by the 3rd layer (123) again) by the 4th layer (124).In layer (125), also have outlet header hole (135), thereby it is arranged as array and makes hole (135) aim at outlet header's seam (131) in the 4th layer (124).
As seen, when layer (121) to (125) is attached together formation duplexer (120), go up most (first) layer (121), the total pipe seam of inlet (126) and the 3rd layer of (123) cooperation by the second layer (122) form the interior inlet house steward of the second layer (122), and it is connected with the abutting end of fluid intake pipe (not shown) in use.
The total pipe seam of inlet (126) by the second layer (122), all be aligned with each other by layer (123), (124), the total pore of inlet (129) of (125), (130), (134), between the nearest face (136) of inlet house steward in the second layer (122) and duplexer (120), cooperation forms and runs through the 3rd layer of total pipeline of inlet to layer 5 (123), (124) and (125).
The 3rd layer (121), the seam of the outlet header by the 4th layer (124) (131) and layer 5 (125) cooperation form the 4th layer (124) interior outlet header, and it is connected with the abutting end of fluid outlet pipe (not shown) in use.
Outlet header's seam (131) by the 4th layer (124) and the outlet header hole (135) by layer 5 (125) are aligned with each other, between the nearest face (136) of outlet header in the 4th layer (124) and duplexer (120), cooperation forms the outlet header's pipeline by layer 5 (125).
With reference to Figure 11, shown in suction, flushing and/or cleansing wounds device be the variant of Fig. 1 device (1).
It has detour (711) around pump (17), the protection pump is resisted intrasystem any fault.
Pump starts automatically by suitable means, as, it is usually by explosion disk (not shown) or the blocking-up of pressure-activated electrodynamic valve.
The another kind of replacement scheme of bypass (711) is intrasystem pressure transducer, and it will monitor overload or excess pressure, and close pump.
With reference to 12, shown in suction, flushing and/or cleansing wounds be the variant of the device (1) of Fig. 2 with device (1).
The device of Fig. 2 is the binary system with dialysis unit (21), dialysis unit but (21) be wherein dialysate only from dialysate bin (not shown) pass in first Room (25) dialyser (28) surface once, enter as in the collecting bag (not shown) as waste liquid via second three-way valve (36) of releasing.
The variant of Figure 12 has the dialysis circulation pipe (811) of traveling between first three-way valve (816) on dialysis pump (23) entrance side and second three-way valve (817), when pipeline is repeatedly poured into, allow pump (23) to make dialysate pass dialysis unit (21) repetitive cycling.
This operation of system it will be apparent to those of skill in the art.
Referring to figs. 13 through 15, provide the dressing of following form: dressing has wound implant (348) under circular backing layer (342).
Wound implant (348) comprises downward cheese or annulus or oblate spherical conformability hollow body usually respectively, and hollow body is limited by the thin film (349) that is full of fluid (being air or nitrogen) here, and this fluid impels hollow body and wound shapes fit.
In backing layer, for example it is attached on the backing layer (342) by heat-sealing implant (348) by means of lobe (351) type of permanent attachment.
Inflation entry conductor (350), inlet tube (346) and outlet (347) are installed in the center of the interior lobe (351) of backing layer (342) on the hollow body (348).Inflation entry conductor (350) communicates with the inside of hollow body (348), and hollow body (348) is expanded.Inlet tube (346) extends through hollow body (348) effectively with the form of conduit (352).Outlet (347) is closely radiation extension under backing layer (342).
In Figure 13, conduit (352) communicates with inlet house steward (353), and inlet house steward (353) is formed by the thin film that has hole (362) (361), and thin film (361) is by sealing type of permanent attachment in implant (348).Inlet house steward (353) is full of the foam (363) that is formed if any the elastic thermoplastic of resilience by suitable material.Preferable material comprises the netted filtering polyurethane foam that has aperture or pore.
In Figure 14, outlet (347) communicates with the layer of the foam (364) that is formed if any the elastic thermoplastic of resilience by suitable material.And preferable material comprises the netted filtering polyurethane foam that has aperture or pore.
In Figure 13,14 and 15, when using dressing, conduit (346) stops with one or more openings, and described opening is directly sent flushing liquor in the areal extent that increases from the wound layer.
Similarly, when using dressing, outlet (347) is radially collected fluid effectively from the wound periphery.
With reference to Figure 16, dressing also has wound implant (348) under circular backing layer (342).
Wound implant (348) comprises also by what the thin film (349) that is full of fluid (being air or nitrogen) here limited and is generally annular conformability hollow body that described fluid impels hollow body and wound shapes fit.
Implant (348) may be by means of first lobe (351) and the froth bed that is formed if any elastic thermoplastic by suitable material (364) type of permanent attachment in backing layer (342).And preferable material comprises the netted filtering polyurethane foam that has aperture or pore.
First lobe (351) and froth bed (364) are heat-sealed in respectively on backing layer (342) and the lobe (351).
Inflation entry conductor (350), inlet tube (346) and outlet (347) are installed in interior first lobe (351) of backing layer (342) on the annular hollow body (348) between two parties.
Inflation entry conductor (350), inlet tube (346) and outlet (347) extend through second lobe (357) that interior central duct (356) arrival of hollow body (348) is attached to annular hollow body (348) with the form of conduit (353), (354) and (355) respectively separately.
Conduit (353) communicates with the inside of hollow body (348), and hollow body (348) is expanded.Conduit (354) radially extends through second lobe (357) and communicates with inlet house steward (352), inlet house steward (352) is by forming by the heat-sealing thin film (361) of type of permanent attachment in implant (348), and the form of thin film (361) is the netted honeycomb that has flushing liquor direct opening (362) of sending to the wound layer in the areal extent that increases.When using dressing, conduit (355) is collected the fluid of Radial Flow from trauma center.
The dressing of this form is the design that is more suitable for than diacope.
In Figure 17, dressings is similar to the dressing of Figure 16, difference is to be full of fluid (being solids here) by the annular conformability hollow body that thin film (349) limits, as plastics bits or plastic bead, rather than gas such as air or noble gas, such as nitrogen or argon, and inflation entry conductor (350) and conduit (353) have been saved from central duct (356).
The example of the content of hollow body (348) also comprises gel, and as silicone gel or preferred cellulose gel, hydrophilic cross-linking cellulose gel for example is as Intrasite
TMCross-linked material.Example also comprises aerosol foam and typing aerosol foam, as CaviCare
TMFoam.
With reference to Figure 18 and 19, be depicted as another kind and be used for form than diacope.This dressing comprises circular backing layer (342) and chamber (363), and the form of chamber (363) is the dish that gets deeply stuck in, the Flos Rosae Rugosae of a plurality of Maltese cross of extraordinary image or fixed pattern.
Chamber (363) is limited by top barrier film (361) and the following porous membrane that has hole (364) (362), and directly send flushing liquor in the areal extent that increases hole (364) from the wound layer.Show the shape of various chambers (363), all these chambers (363) can both be conformal fully by the also possible eclipsed arm of sealing and the wound floor that are inserted in the wound.
In the specific design of chamber (363), shown in nethermost figure, one of arm extends and has inlet at the end of adjutage.This in use provides the flushing liquor supply combination and the isolating chance that are used to make away from dressing and wound.
Inlet tube (346) and outlet (347) be installed in the lobe (351) in the backing layer (342) on the chamber (363) in the heart.Therefore inlet tube (346) type of permanent attachment forms the inlet house steward effectively in the chamber (363) and communicate with the inside of chamber (363).Be full of loose gauze packing (364) between between on the chamber (363).
In Figure 18, outlet (347) from backing layer (342) in the face of under the face (343) of wound from dressing internal gathering fluid.
The variant of the dressing of Figure 18 as shown in figure 19.Outlet (347) is installed as and enters in the foam block (374), and (363) go up spatial minimum point opening in the chamber.
In Figure 20, dressings is similar to the dressing of Figure 13, difference is that inlet tube (352) communicates with inlet house steward (353), inlet house steward (353) is formed by the thin film that has hole (362) (361), inlet tube (352) is positioned at the top of the upper surface of the hollow filling thing of cheese wound (348) that is generally downward, rather than passes hollow filling thing.
In Figure 22, dressings is similar to the dressing of Figure 14, and many inlet house steward (353), it is formed by the thin film that has hole (362) (361), and the inlet house steward is above the lower surface that is generally the downward hollow filling thing of cheese ring-type wound.
In Figure 21, saved the hollow filling thing of cheese ring-type wound that is generally downward.
With reference to Figure 23, be depicted as another kind and be used for form than diacope.Inlet tube (346) and outlet (347) are installed in the interior center of lobe (351) in the backing layer (342) that blocks on the foam-filled thing (348).Inlet tube (346) type of permanent attachment is in implant (348) and pass implant (348) arrival wound layer.Outlet (347) is attached to chamber (363) and communicates with the inside of chamber (363), and chamber (363) are limited by the porous foam that is attached to implant (348) upper periphery.Chamber (363) therefore forms the outlet header effectively.
In Figure 24, foam-filled thing (348) just part blocks (sealed-off).Inlet tube (346) type of permanent attachment is in implant (348) and pass implant (348) arrival wound layer.Outlet (347) is attached to the foam of implant (348) and communicates with the foamy inside of implant (348).Fluid passes the annular gap (349) that foam enters close implant (348) upper periphery, and annular gap (349) forms the outlet header effectively.
Figure 25 and 26 shows the dressing that wherein inlet tube (346) and outlet (347) pass backing layer (342).
In Figure 25, they communicate with the inside of porous bag shape implant (348), and porous bag shape implant (348) is limited by porous membrane (369) and has been full of resilient plastic bead or plastics bits.
In Figure 26, they communicate with wound space under the foam-filled thing (348).Foam (348) can be the CaviCare that also forms on the spot that is injected into conduit (346) and (347) on every side
TMFoam.
With reference to Figure 27, suction, flushing and/or cleansing wounds are most of variant of device shown in Figure 1 with device (1).
The equipment that is used among Fig. 1 make fluid move through wound and fluid purification mechanism (17) is peristaltic pump (18), as is preferably the small portable peristaltic pump, and it acts on dressing (2) fluid downstream circulation pipe (13), and wound is applied low negative pressure.
In device shown in Figure 27 (1), peristaltic pump (18) is replaced by following pump, wound is applied low negative pressure:
A) act on dressing (2) upstream fluid supply line (7) peristaltic pump and
B) have the vacuum pump unit of pressure regulating device, act on dressing (2) fluid downstream circulation pipe (13).
Above-mentioned vacuum pump unit comprises groove (911), and groove (911) has:
Be connected with fluid circulation tubes (13) and with the top inlet communicating pipe (912) of groove (911),
The sewer pipe (913) that is connected and communicates with the waste drains pump that has waste fluid bag (915) (914) with the bottom of groove (911),
The pump line (916) that is connected with vacuum pump (918) and communicates with the top of groove (911) and
The outlet (917) that is connected and communicates with the fluid circulation tubes (13) that arrive to purify mechanism (17) with the bottom of groove (911).
Vacuum pump (918) is controlled by power transmission line (920) by pressure feedback actuator (919), actuator receives from the signal of the sensor slot (921) on groove (911) top and the signal of the dressing pick off (922) in the wound space by means of line (923) and (924) respectively.
The class of operation of device (1) is similar to the operation of installing among Fig. 1, in addition necessary change.
The pressure that pressure feedback actuator (919) adjusting wound and/or groove (911) are located.
If fluidic amount is excessive in the circulation, as oozing out in a large number constantly because of wound, then waste drains pump (914) can start, and will arrive in the waste fluid bag (915) from the fluid transfer of groove (911) bottom.
The use of device of the present invention will illustrate by the following embodiment that represents with way of example.
Embodiment 1-removes biological load (bioburden) from the monophase system micro-filtration, comprises microorganism
By gamma-radiation sterilization uniline, described uniline but has sample port S1 and as the 0.22 aseptic μ m filter filter plant downstream that purifies mechanism sample port S2 is being arranged basically as shown in fig. 1 between wound dressing and pump.
At inoculation test biology (S.aureus NCTC 10788) before, be full of the wound bin, inoculate MRD with test organism then, obtain final concentration 10 with the aseptic MRD of 45ml (maximum recovery diluent)
4Cfu/ml.
Make before culture circulates in filter plant, make it center on circuit circulate in advance (walking around 0.22 aseptic μ m filter).Took out the sample (0.5ml) of pre-circulation of fluid from port S1 at 30 and 60 minutes.With its serial dilution to 10 in MRD
-3And prepare double 1ml tryptone soy agar (TSA) sheet from each dilution according to standard checking rules.The counting before with sheet 32 ℃ of cultivations at least 72 hours.
After 1 hour, make fluid cycle through filter plant.Take out 0.5ml sample from port S1 with T=0,20,40,60 and 80 minutes from port S2 T=10,30,50 and 70 minutes, all samples are counted as mentioned above.
The result
Table 1: derive from the count of bacteria of the pre-circulation of fluid of monophase system
Sample time (minute) | Average counter (cfu/ml) | ??Log 10Counting (cfu/ml) |
??30 | ??2.31×10 4 | ??4.36 |
??60 | ??1.87×10 4 | ??4.27 |
Table 2: derive from the fluidic count of bacteria behind the wound bin (port S1) passed through of single-phase Exudialysis system
Sample time (minute) | Average counter (cfu/ml) | ??Log 10Counting (cfu/ml) |
??10 | ??6.30×10 3 | ??3.80 |
??30 | ??4.10×10 3 | ??3.61 |
??50 | ??1.77×10 3 | ??3.25 |
??70 | ??1.23×10 3 | ??3.09 |
Table 3: derive from the fluidic count of bacteria behind the wound bin (port S2) passed through of single-phase Exudialysis system
Sample time (minute) | Average counter (cfu/ml) | ??Log 10Counting (cfu/ml) |
??0 | ??<1.0×10 1 | ??<1.00 |
??20 | ??<1.0×10 1 | ??<1.00 |
??40 | ??<1.0×10 1 | ??<1.00 |
??60 | ??1.0×10 1 | ??1.00 |
??80 | ??<1.0×10 1 | ??<1.00 |
Conclusion
By after the 0.22 μ m filter, monophase system can be immediately removed bacterial cell and is caused the minimizing gradually of circulation total number of bacteria from the wound circuit with about 3 orders of magnitude.
Embodiment 2-in binary system (static second phase) to the inhibition of elastoser
A) preparation-4-of immobilization elastoser antagonist (2-aminoethyl) benzene sulfonyl fluorine (AEBSF) and poly-(maleic anhydride-alt-methyl vinyl ether) and with the preparation of the conjugate (inhibitor) of 5-(2-aminoethyl amino)-1-naphthalene sulfonic aicd (EDANS) fluorescent marker of 1%
In the solution of the MAMVE of magnetic agitation (1.646g, 10.5mmol unit) in DMF (100ml), add EDANS (30.4mg, 0.1mmol) solution in DMF (2ml).After 15 minutes, drip the AEBSF hydrochlorate (2.502g, 10.4mmol) and triethylamine (1.056g, 10.4mmol) solution in DMF (20ml).After 5 hours, this solution dropwise is deposited among the 0.5M HCl (2000ml), Buchner filters and washes with 0.5M HCl.The product vacuum drying, and-4 ℃ of storages.Yield 3.702g, 98%.
In the solution of the MAMVE of magnetic agitation (2.000g, 12.8mmol unit) in DMF (100ml), add EDANS (37.0mg, 0.1mmol) solution in DMF (2ml).After 15 minutes, dropwise add phenethylamine (1.537g, 12.7mmol) solution in DMF (10ml).After 5 hours, this solution dropwise is deposited among the 0.5M HCl (2000ml), Buchner filters and washes with 0.5M HCl.The product vacuum drying is to dry, and storage at room temperature.Yield 3.426g, 97%.
B) elastoser suppresses
Use basically two-phase circuit as shown in Figure 1, the two-phase with static second phase purifies mechanism, has sample port in the downstream that purifies mechanism.
Purifying mechanism is MiCroKros Cross Flow Syringe Filter (SpectrumLabs Inc) PS/400K MWCO 8cm
2, having two independently chambers, the outer any fluid of holding chamber is static.
Be full of the mistress and connect with 2mg/ml inhibitor solution (the TRIS solution of~1ml) in pipeline.Inlet tube and outlet place TRIS solution, and make TRIS pour in inner room by the MiCoKros syringe and pipeline 5 minutes.Empty pipeline then, the elastoser (0.311mg/ml) of 2ml is added drop-wise in the wound circulation.
Pipe is placed bin and starts pump and timer simultaneously.
In 6 hours, per hour take out 10 microlitre samples and after sampling, analyze with following manner immediately from the wound circuit.Analyze static elastoser contrast at each time point, to be determined at active reduction in 6 hours.
C) elastase activity analysis
Preparation elastin laminin zymolyte N-Succ-(Ala)
3-nitronilide (the DMSO solution of 10mg/ml).N-Succ-(Ala) with 25 microlitres
3-nitronilide (the DMSO solution of 10mg/ml) joins among the TRIS of the 2.475ml in the disposable cuvette of 4.5ml capacity.Before losing efficacy, the elastin laminin enzymatic solution of estimating to join cuvette finished mixings (fully mixing) in 10 minutes with the assurance substrate.Then 10 microlitre samples are joined in each cuvette and fully and mix.Culture sample 40 minutes and be recorded in the absorbance of 405nm at room temperature.
Result and conclusion
??TRIS | |||||
Time/ | Test | 1 | |
|
The elastoser contrast |
??0 | ??0.266 | ??0.284 | |||
??1 | ??0.255 | ??0.258 | ??0.239 | ??0.283 | |
??2 | ??0.271 | ??0.242 | ??0.225 | ??0.284 | |
??3 | ??0.219 | ??0.218 | ??0.209 | ??0.291 |
??TRIS | ||||
??4 | ??0.208 | ??0.203 | ??0.203 | ??0.277 |
??5 | ??0.197 | ??0.17 | ??0.194 | ??0.304 |
??6 | ??0.198 | ??0.161 | ??0.182 | ??0.288 |
Elastoser is final | ??0.267 | ??0.289 | ??0.281 |
Table 1: the absorbance (405nm) that after cultivating 40 minutes, detects elastoser+TRIS.Each is tested triplicate and per hour writes down static elastoser contrast.
Table 2: the absorbance (405nm) that after cultivating 40 minutes, detects elastoser+MAMVE-AEBSF.Each is tested triplicate and per hour writes down static elastoser contrast.
The meansigma methods of all elastoser controlled trials is used to calculate 0 hour 100% activity.
The elastase activity average percentage of 3:3 variable of table has the SD data
The result shows, for elastoser+Tris solution, and active decline 60-70%.This may be interpreted as the blended dilution effect of TRIS (2/3) owing to 2ml elastoser in the mistress and 1ml.This shows that system is inert for elastoser, in 3 hours, take place to mix fully/by film diffusion.
Elastoser+MAMVE-AEBSF proteinase activity that demonstrates flexibility has 90% decline in 6 hours.
Embodiment 3: from binary system (static second phase) chelated iron ion
Use basically binary system as shown in fig. 1, the two-phase with static second phase purifies mechanism, in the downstream that purifies mechanism sample port is arranged, purification mechanism is dialysis cassette (Pierce, 10, the 000MWCO in the Slide-A-Lyzer chamber, the 3-15ml capacity, production number #66410).
In dialysis cassette, load following material:
A) phosphate buffer saline of 5ml (PBS),
B) starch contrast (40,120 and 200mg/ml) or
C) solution of starch-desferrioxamine (DFO) conjugate (providing) (40,120 and 200mg/ml) by Biomedical Frontiers Inc..
Each dialysis cassette places the Slide-A-Lyzer chamber.In this layout, by above-described 10, the 000MWCO thin film separates the tote in the dialysis cassette from the circulation first fluid.
Transferrins (10mg/ml, 35 volumes) is injected in the sample port, and makes it with different flow (0.54,0.82,1.08 and 1.35ml/min) circulation 8 hours in running system by Masterflex pump (model 7523-37).
Collected sample at 0,2,4,6 and 8 hour.
Use luxuriant and rich with fragrance alloxazine (ferrozine) to be analyzed as follows the iron content of measuring samples: sample to be mixed with the 50mM acetate buffer of pH4.8, to discharge ferrum from transferrins.Add ascorbic acid (30mM) to sample and be reduced to Fe (II) ion with Fe (III) ion that will discharge.With luxuriant and rich with fragrance alloxazine (5mM) and sample mix, form the colour developing complex with Fe (II) ion.Use UNICAM UV4-100UV-Vis spectrophotometer V3.32 (serial number 022405) to measure absorbance.
Result and conclusion
Starch-DFO catches ferrum in the dose dependent mode from transferrins in 8 hours.At the ferrum of removing about 20-25% in the presence of starch-DFO of 200mg/ml in circulation after 8 hours.
In the presence of contrast of the starch of variable concentrations or PBS, the iron content of transferrins is because dilution effect and slight decline, but recovers again normally at leisure, shows that the ferrum of being caught by starch-DFO reconciled separately by DFO.
The ferrum of transferrins is caught class of a curve seemingly under the different flow, shows that flow shifts not influence to the ferrum by dialyzer.
Embodiment 4-is from second phase (dynamic second phase) the perfusion antibiotic of binary system
Use basically two-phase blood circulation as shown in fig. 1, it has basically second (dialysate) circuit as shown in Figure 2.The pump creeping effect is in the siloxanes pipe.Second circuit has dialysate bin (50ml Falcon centrifuge tube), is used to change wound fluid.The wound circuit is connected to fore shaft engages the tangential thin film unit with dialysis of hollow fibre (Spectrum
MicroKros
X14S-100-04N, surface area 8cm
2, mole cutoff value 400KD) the end in.The dialysis circuit is connected to the side opening of same unit with dialysis, thereby makes wound circuit and flowing of dialysis circuit be countercurrent direction.
According to the description of manufacturer, at first, pour into sterilized water then with ethanol perfusion wound circuit.Be full of the wound bin with the 20ml sterilized water.To be set at 100 speed operation wound pump, it is created in the flow of the 2.09ml/min that measures in the wound circuit.According to the description of manufacturer, at first, pour into sterilized water then with ethanol perfusion dialysis circuit.Be full of the dialysis bin with the 20ml sterilized water.To be set at 100 speed operation dialysate pump, it is created in the flow of the 1.93ml/min that measures in the dialysis circuit.Obtain sample (1ml) by one section silica gel tube from wound and dialysate, this silica gel tube has the fore shaft that is connected with the 2ml syringe and engages.
When on-test, remove the 5ml sterilized water and add 5mg/ml sulmycin solution (EP standard sulmycin, the CRS of 5ml from the dialysate bin; (active 616IU/mg)).Start wound pump and dialysate pump simultaneously.In 230 minutes, obtain sample from dialysis circuit and wound circuit at set intervals.In process of the test, there is not volume to be replaced.
Also measure at the UV of 190nm absorbance with 2ml sterilized water dilute sample (1ml), use the standard curve that generates in advance to obtain moving to the approximate measure result of the gentamycin of wound circuit from the dialysis circuit.
According to using staphylococcus epidermidis (Staphylococcus epidermidis), with the quantitative zone of the active inhibition analysis of gentamycin sample is analyzed subsequently subsequently as indicator bacteria analysis method.
Result and conclusion
The result in the fluidic antimicrobial acivity zone in the inhibition analysis shows, the level of the gentamycin in the wound circuit is stable increasing in 230 minutes, and the speed of its increase is closer to each other and slow down along with two circuit Chinese medicine levels.The gentamycin water-glass of dialysis in the circuit reveals stable reduction, if as the medicine of expectation from the dialysis circuit moves to the wound circuit.In clinical practice, under available pressure and the flow, can send the medicine that is used for wound healing with acceptable amount and acceptable time-histories.
The regeneration of embodiment 5-glutathion (glutathion reductase (GR) and cofactor NADP (reduction form) by localization in binary system (static second phase) are reduced to glutathion (GSH) with the glutathion (GSSG) of oxidation)
Use basically two-phase circulation as shown in fig. 1, use two-phase mechanism, have sample port in the downstream that purifies mechanism with static second phase, described purification mechanism is dialysis cassette (Pierce, 10, the 000MWCO in the Slide-A-Lyzer chamber, the 3-15ml capacity, production number #66410).
In the inner chamber of the Slide-A-Lyzer box of independent 15ml capacity, inject following every kind of stock solution of 5ml:
A) NADP of the 2mg/ml that in distilled water, prepares (NADP)
B) glutathion reductase of the 2mg/ml that in the NADP stock solution, prepares (GR+NADP)
C) glutathion reductase of the 2mg/ml that in distilled water, prepares (GR)
Every kind of stock solution prepares three parts.
Add with the dialysis cassette horizontal and in the exocoel on box top be divided into aliquot 15ml GSSG stock solution (at 50 μ m GSSG (30.6ml/l) of distilled water preparation.Make it around the first phase line cycle.Per hour sampling (1ml) from the first phase circuit in amounting to 6 hours, and add in the disposable UV cuvette of 1.5ml capacity.In latter stage during this period of time, analyze each aliquot with glutathion assay kit (deriving from Calbiochem).Three numerical value mean deviations are measured the SD of each data point.Be depicted as the curve of the GSSG concentration of each system in three contradistinction systems with these data to the time.
Result and conclusion
Bigger than the independent degree of GR or NADP consumption of using significantly by GR with the GSSG that combines consumption of its cofactor NADP.Therefore, consumption can not be owing to non-specific binding.Under described enzyme and cofactor concentration, at the GSSG of 6 hours internal consumptions about 40%.
Embodiment 6-removes the self-induction body that degerms from the monophase system degraded
The exchange that is called the extracellular signaling molecule of self-induction body is utilized by antibacterial, and it is absolutely necessary for the collaborative of activatory crucial bacterial virulence gene expression under critical bacterial cell density, thereby and realizes that successful bacterial colonization and tissue encroach on.This system is called QuorumSensing.On the contrary, (being generally enzymatic) of self-induction body degraded or chelating are a kind of methods of destroying necessary traffic and helping the prevention traumatic infection.
The AiiA enzyme is the degradation agent of 3-oxo dodecyl homoserine lactone signaling molecule, and described signaling molecule is used as the self-induction body by S.aureus.
The AiiA enzyme that uses is produced by University of Nottingham, and it is incorporated into maltose-binding protein.
A) with the preparation of the bonded AiiA enzyme of polymer support
The agarose gel 6MB (deriving from Sigma) (200-300 μ m diameter is used for the higher flow that passes through) of washing cyanogen bromide-activated and with its immersion and expanded 30 minutes in 1mM hydrochloric acid.With a large amount of distillation washing gels, use NaHCO then
3/ NaCl (pH 8.5) washes, and exists side by side promptly to use.
In the polymer support globule, add AiiA enzymatic solution (about 1mg/ml) and make it 4 ℃ of standing over night.NaHCO with pH 8.5
3/ NaCl washs link coupled globule and it is stored as slurry.The washing liquid of collecting globule to be measuring the not amount of link coupled enzyme, and measures coupling efficiency thus.
Use barren not coupling globule in contrast.
Holding back the not commensurability enzyme coupling globule of 1mg, 10mg and 100mg by two glass sintering bodies of column glass infuser (this column glass infuser have be used for axial entrance and the outlet that fluid passes through) chamber that limits, it forms the purification mechanism in the monophase system, also has sample port in the downstream that purifies mechanism.Pass through the chamber with 6 hours stock solutions with 1.93ml/min at the 3-oxo dodecyl homoserine lactone (ODHSL) of 37 ℃ of following pumping 10 μ m.
In amounting to 6 hours,, add in the disposable UV cuvette of 1.5ml capacity per hour from circulation of fluid sampling (1ml).
At the end of this period, use people 1997 such as Swift, J.Bacteriol., each aliquot of the analytical among the 179:5271-5281, described analytical method is used based on the plasmid reporting system in the escherichia coli of bioluminescence.The 100mg sample shows ODHSL concentration in 6 hours 86% reduction.
Claims (19)
- One kind be used to aspirate, the conformability wound dressing (2 of the device of flushing and/or cleansing wounds; 41), this dressing (2; 41) comprising:(i) has the backing layer (3 that to go up the face (43) of facing wound that forms fluid-tight relatively sealing or sealing (4) in wound (5); 42) and(ii) at least one inlet tube (6; 46), it is connected with fluid supply line (7), and pass in the face of the face of wound and/or in the face of under the face of wound and(iii) at least one outlet (9; 47), it is connected with fluid discharge pipe (10), and passes in the face of the face of wound and/or in the face of under the face of wound,Pass in the face of the face of wound and/or in the face of the point (8 under the face of wound at described at least one inlet tube and described at least one outlet; 11) on wound, form fluid-tight relatively sealing or sealing,(iv) the wound implant is characterized in that wound implant (48; 69; 79; 95; 110; 348) be the form of one or more conformability hollow bodies, or comprise one or more conformability hollow bodies, described conformability hollow body is limited by film, sheet or thin film, wherein has been full of to promote the wound implant and make itself and conformal fluid or the solid of wound shapes.
- 2. the dressing of claim 1, wherein said wound implant are bag, chamber or pouch, wherein have been full of to promote the wound implant and make itself and conformal fluid or the solid of wound shapes.
- 3. claim 1 or 2 dressing, wherein said fluid is a gas.
- 4. claim 1 or 2 dressing, wherein said fluid is a liquid.
- 5. claim 1 or 2 dressing, wherein said fluid or solid are gels.
- 6. each the dressing of aforementioned claim, wherein said wound implant provides on backing layer.
- 7. each dressing of claim 1-5, wherein said wound implant provides below backing layer.
- 8. each the dressing of aforementioned claim, wherein said wound implant and dressing become one.
- 9. the dressing of claim 8, wherein said wound implant and backing layer become one.
- 10. each dressing of claim 1-7, wherein said wound implant removably is attached to backing layer.
- 11. each the dressing of aforementioned claim, wherein said dressing further comprises the second wound implant, and the described second wound implant is that solid is whole or comprise solid integral body.
- 12. the dressing of claim 11, wherein said one or more conformal gonosomes part at least center on described solid integral body.
- 13. the dressing of claim 11 or 12, wherein said solid integral body is foam.
- 14. the dressing of claim 13, wherein said foam are the netted filtering polyurethane foams.
- 15. each dressing of aforementioned claim, wherein said wound implant comprises by what film, sheet or thin film limited an elastic hollow body of resilience, have hole, hole, opening, aperture, crack, seam, pipe, conduit, pipe or the mouth of pipe, and communicate with at least one inlet tube or outlet by at least one hole, hole, opening, aperture, crack or seam, this wound implant forms inlet house steward or outlet header, and this inlet house steward or outlet header directly send circulation of fluid or directly from wound collection fluid to the wound layer.
- 16. having, each dressing of claim 1-15, wherein said implant is used to allow fluid to arrive the device of the wound layer under the wound dressing.
- 17. the dressing of claim 16, the wherein said device that is used to allow fluid to arrive the wound layer under the wound dressing is the form of conduit, pipe, tubule or the mouth of pipe, and it passes backing layer in the face of the face of wound and/or in the wound implant or the traveling around the wound implant that begin in the face of the point under the face of wound below backing layer at fluid intake pipe and outlet.
- 18. each dressing of claim 7-17, wherein said dressing comprises:Backing layer (342),Conformability hollow body (363), described conformability hollow body (363) is limited by top barrier film (361) and the following porous membrane that has hole (364) (362), the form of this hollow body is the dish that gets deeply stuck in, thereby forms many from the extraradial arm of mind-set whereinInlet tube (346) and outlet (347), they be installed in the lobe (351) on the hollow body (363) in the heart, wherein inlet tube communicates with the inside of chamber, so this hollow body forms the house steward that enters the mouth, and outlet from backing layer in the face of collect under the face of wound fluid andSecond wound dressing (364), it is for being full of the form of the spatial loose gauze packing on the hollow body (363).
- 19. the dressing of claim 18, wherein said hollow chamber can be conformal by being inserted into sealing in the wound and optional eclipsed arm and wound.
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- 2003-10-28 AT AT03809377T patent/ATE450289T1/en active
- 2003-10-28 US US10/533,275 patent/US7524315B2/en not_active Expired - Fee Related
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